FDAsafety guidance77% confidence
FDA TA — BINIMETINIB (ORIG)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Alembic Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA217678. Sponsor: ALEMBIC PHARMS LTD. Submission status: TA. Submission type: ORIG. Review priority: STANDARD. Active ingredients: BINIMETINIB.
Supporting Context
- Therapeutic area
- Pain Management · COX-2 Inhibitor
- Sub-indication
- Pain
Related signal: FDA Accepts Supplement Application for Celecoxib by Alembic