FDAsafety guidance66% confidence
FDA AP — BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Alembic Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA075231. Sponsor: LGM PHARMA. Submission status: AP. Submission type: SUPPL. Active ingredients: ASPIRIN, BUTALBITAL, CAFFEINE, CODEINE PHOSPHATE.
Supporting Context
- Therapeutic area
- Infectious Disease · Antiviral
- Sub-indication
- General
Related signal: Alembic's Oseltamivir Phosphate ANDA Submission Receives AP Status