FDAsafety guidance54% confidence
FDA AP — LAMOTRIGINE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Glenmark Pharmaceuticals.
Regulatory Analysis
Application ANDA079099. Sponsor: GLENMARK PHARMS LTD. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LAMOTRIGINE.
Supporting Context
- Therapeutic area
- Neurology · Antiepileptic
- Sub-indication
- General
Related signal: Glenmark Pharmaceuticals submits supplemental application for Lamotrigine