FDAsafety guidance66% confidence
FDA AP — DIVALPROEX SODIUM (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 ANDA077567. Sponsor: MYLAN. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: DIVALPROEX SODIUM.
Supporting Context
- Therapeutic area
- Neurology · Antiepileptic
- Sub-indication
- General
Related signal: FDA Approval Update for Divalproex Sodium by Mylan