FDAsafety guidance66% confidence
FDA AP — SAXENDA (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 NDA206321. Sponsor: NOVO. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LIRAGLUTIDE.
Supporting Context
- Therapeutic area
- Endocrinology · GLP-1 Agonist
- Sub-indication
- General
Related signal: FDA Grants Approval for Mylan's Liraglutide ANDA213155