FDAsafety guidance72% confidence
FDA AP — TOPIRAMATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to AbbVie.
Regulatory Analysis
Application ANDA079162. Sponsor: INVAGEN PHARMS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: TOPIRAMATE.
Supporting Context
- Therapeutic area
- Neurology · Migraine
- Sub-indication
- General
Related signal: APT Comparison Study to Evaluate Atogepant vs. Topiramate and Propranolol for Migraine Prevention