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 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Accutane (isotretinoin) is a oral retinoid that inhibits sebaceous gland function and keratinization, approved in 1982 for severe nodular acne. It works by reducing sebum secretion through suppression of sebaceous gland differentiation and size. The drug is highly lipophilic and requires administration with high-fat meals to maximize bioavailability.
$0.083BPart D
LOE ApproachingDeclining market position with low Part D claims volume (424 in 2023) signals a mature, niche market with limited growth opportunities for large commercial teams.
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.