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 Merck Sharp & Dohme LLC.
Regulatory Analysis
Application ANDA075824. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Active ingredients: BUTORPHANOL TARTRATE.
Supporting Context
- Therapeutic area
- Genetics · Familial Mediterranean Fever
- Sub-indication
- Rare Disease
Related signal: Study on Genetics of Familial Mediterranean Fever and Related Disorders Launched