Repurposing candidates

Studied as a therapy for perimenopause & menopause in 2 interventional trials · highest reached no phase listed · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 3 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 1 interventional trial · highest reached no phase listed · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 4 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 1 interventional trial · highest reached no phase listed · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 11 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “atment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1.1 ) The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atroph”

Brand-only, patent-protected. Single-source brand with at least one unexpired Orange Book patent (latest listed expiry Jul 2028).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 3 interventional trials · highest reached Phase 2 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 3 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 1 interventional trial · highest reached Phase 3 · halted/terminated.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “atment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom o”

Brand-only, patent-protected. Single-source brand with at least one unexpired Orange Book patent (latest listed expiry Mar 2031).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 1 interventional trial · highest reached no phase listed · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 5 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Only in combination products. Appears only inside combination products, not as a stand-alone single-ingredient product.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 38 interventional trials · highest reached Phase 3 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “stradiol valerate injection, USP) is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and va”

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 1 interventional trial · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “DICATIONS AND USAGE ENJUVIA tablets are indicated in the: Treatment of moderate to severe vasomotor symptoms associated with menopause. Treatment of moderate to severe vaginal dryness and pain with in”

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 38 interventional trials · highest reached Phase 3 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “ated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. CONTRAINDICATIONS Estradiol Vaginal Cream, 0.01% should not be used in women with any of the follow”

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 4 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “strogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. (1.1) Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.”

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 3 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 4 interventional trials · highest reached Phase 3 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 1 interventional trial · highest reached no phase listed · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for perimenopause & menopause in 1 interventional trial · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “estin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atr”

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 4 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 24 interventional trials · highest reached Phase 3 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 33 interventional trials · highest reached Phase 3 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 109 interventional trials · highest reached Phase 3 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 39 interventional trials · highest reached Phase 3 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 1 interventional trial · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 2 interventional trials · highest reached Early Phase 1 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 2 interventional trials · highest reached no phase listed · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 28 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “ose patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome,”

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 5 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 10 interventional trials · highest reached Phase 2 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Discontinued. Previously approved but no longer actively marketed in the Orange Book.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 1 interventional trial · highest reached Phase 2 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Brand-only, patent-protected. Single-source brand with at least one unexpired Orange Book patent (latest listed expiry Oct 2043).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 20 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pcos in 1 interventional trial · highest reached Phase 2 · halted/terminated.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for endometriosis in 1 interventional trial · highest reached Phase 2 · halted/terminated.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for endometriosis in 12 interventional trials · highest reached Phase 3 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Only in combination products. Appears only inside combination products, not as a stand-alone single-ingredient product.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for endometriosis in 1 interventional trial · highest reached no phase listed · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Only in combination products. Appears only inside combination products, not as a stand-alone single-ingredient product.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for endometriosis in 7 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “USAGE ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see”

Brand-only, patent-protected. Single-source brand with at least one unexpired Orange Book patent (latest listed expiry Aug 2040).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Brand-only. Single-source brand with no unexpired Orange Book patent currently listed.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for endometriosis in 4 interventional trials · highest reached Phase 3 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “iomyomas (fibroids). ( 1.1 , 14.1 ) management of moderate to severe pain associated with endometriosis. ( 1.2 , 14.2 ) Limitations of Use Use of MYFEMBREE should be limited to 24 months due to the ri”

Brand-only, patent-protected. Single-source brand with at least one unexpired Orange Book patent (latest listed expiry Sep 2037).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for endometriosis in 3 interventional trials · highest reached Phase 2 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for endometriosis in 4 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “"2.16.840.1.113883.6.1" displayName="INDICATIONS & USAGE SECTION"/> INDICATIONS AND USAGE Endometriosis Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal managemen”

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for endometriosis in 2 interventional trials · highest reached Phase 3 · halted/terminated.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Discontinued. Previously approved but no longer actively marketed in the Orange Book.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for endometriosis in 1 interventional trial · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for vulvodynia in 3 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for vulvodynia in 1 interventional trial · highest reached no phase listed · halted/terminated.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for vulvodynia in 3 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for vulvodynia in 1 interventional trial · highest reached Phase 3 · status unclear.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for vulvodynia in 6 interventional trials · highest reached Phase 2 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for adenomyosis in 2 interventional trials · highest reached Phase 1 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Only in combination products. Appears only inside combination products, not as a stand-alone single-ingredient product.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for adenomyosis in 2 interventional trials · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for adenomyosis in 1 interventional trial · highest reached Phase 3 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Brand-only. Single-source brand with no unexpired Orange Book patent currently listed.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for adenomyosis in 1 interventional trial · highest reached Phase 2 · halted/terminated.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for adenomyosis in 2 interventional trials · highest reached Phase 3 · active trial(s).

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for adenomyosis in 2 interventional trials · highest reached Early Phase 1 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Brand-only, patent-protected. Single-source brand with at least one unexpired Orange Book patent (latest listed expiry Jun 2029).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for adenomyosis in 1 interventional trial · highest reached Phase 2 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Brand-only, patent-protected. Single-source brand with at least one unexpired Orange Book patent (latest listed expiry Sep 2032).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for adenomyosis in 1 interventional trial · highest reached Phase 1 · completed.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Brand-only, patent-protected. Single-source brand with at least one unexpired Orange Book patent (latest listed expiry Jun 2031).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “D) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride tablets are a selective serotonin reuptake inh”

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pmdd in 1 interventional trial · highest reached Phase 2 · halted/terminated.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “use by females of reproductive potential to: Prevent pregnancy. ( 1.1 ) Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contrac”

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Discontinued. Previously approved but no longer actively marketed in the Orange Book.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Off-label. The drug has an FDA-approved label, but for a different indication, so using it for this condition would be off-label.

Generic available. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

Studied as a therapy for pmdd in 1 interventional trial · highest reached Phase 2 · halted/terminated.

Source: ClinicalTrials.gov (U.S. National Library of Medicine).

On-label (FDA-approved for this use). This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.Label: “use by females of reproductive potential to: Prevent pregnancy. ( 1.1 ) Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contrac”

Brand-only, patent-protected. Single-source brand with at least one unexpired Orange Book patent (latest listed expiry Jun 2031).

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).

No FDA-approved label. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.

Not in the Orange Book. Absent from the Orange Book. Biologics (listed in the Purple Book instead), dietary supplements, and drugs not FDA-approved in the US do not appear here.

This is where the candidate sits in the regulatory landscape: descriptive context, not a 505(b)(2) viability assessment or regulatory advice.

Sources: FDA Orange Book; DailyMed (U.S. National Library of Medicine).