FDAsafety guidance72% confidence
FDA AP — BUTORPHANOL TARTRATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (rare disease) as Prevail Therapeutics.
Regulatory Analysis
Application ANDA075499. Sponsor: APOTEX. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
Supporting Context
- Therapeutic area
- Genetic Disorders · Gaucher Disease
- Sub-indication
- Rare Disease
Related signal: Phase 1/2 Trial of LY3884961 for Gaucher Disease Initiated by Prevail Therapeutics