FDAsafety guidance72% confidence
FDA AP — BUTORPHANOL 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 ANDA075499. Sponsor: APOTEX. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL 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