FDAsafety guidance72% confidence
FDA AP — LEVORPHANOL TARTRATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Roche.
Regulatory Analysis
Application ANDA211484. Sponsor: ACERTIS PHARMS. Submission status: AP. Submission type: SUPPL. Active ingredients: LEVORPHANOL TARTRATE.
Supporting Context
- Therapeutic area
- Gastroenterology · Crohn's Disease
- Sub-indication
- General
Related signal: Phase III Trial of Afimkibart Shows Promise for Moderately to Severely Active Crohn's Disease