FDAsafety guidance66% confidence
FDA AP — FENTANYL-37 (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Mylan; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA076258. Sponsor: MYLAN TECHNOLOGIES. Submission status: AP. Submission type: SUPPL. Active ingredients: FENTANYL.
Supporting Context
- Therapeutic area
- Endocrinology · GLP-1 Agonist
- Sub-indication
- General
Related signal: FDA Grants Approval for Mylan's Liraglutide ANDA213155