NDAORALCAPSULEPriority Review
Approved
May 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
ACCUTANE (isotretinoin) by Roche is clinical pharmacology isotretinoin is a retinoid, which when administered in pharmacologic dosages of 0. First approved in 1982.
Drug data last refreshed 6h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Accutane (isotretinoin) is a potent oral retinoid approved in 1982 for severe nodular acne that is unresponsive to conventional therapies. It works by inhibiting sebaceous gland function and keratinization, leading to sustained reduction in sebum secretion and long-term clinical improvement. Isotretinoin remains the only drug with curative potential in severe acne, though it carries significant teratogenic and safety risks.
$0.083BPart D
LOE ApproachingProduct is in late lifecycle with limited Part D claims (424 annually), indicating a niche market with declining brand team expansion opportunities.
Mechanism of Action
CLINICAL PHARMACOLOGY Isotretinoin is a retinoid, which when administered in pharmacologic dosages of 0.5 to 1 mg/kg/day (see ), inhibits sebaceous gland function and keratinization. The exact mechanism of action of isotretinoin is unknown. Nodular Acne Clinical improvement in nodular acne patients…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.