FDAsafety guidance66% confidence
FDA AP — ABSORICA LD (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Sun Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA211913. Sponsor: SUN PHARM. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ISOTRETINOIN.
Supporting Context
- Therapeutic area
- Dermatology · Acne
- Sub-indication
- General
Related signal: FDA Accepts Supplement Application for Absorica by Sun Pharma