FDA Delays Approval for Migraine Drug Trexima
Trexima, a combination of sumatriptan (Imitrex) and naproxen sodium (found in Aleve and other NSAIDs), was expected to receive FDA approval last week. Requesting more safety data, the FDA has delayed approval of Trexima.
The concern is about one of the four tests of genotoxicity, which is toxicity to DNA. The requested data are available from a study that has already been conducted. The FDA will meet with Pozen and GSK soon to discuss additional requirements.
Related posts:
- Trexima Aborts Migraines Better Than Imitrex or Aleve Alone
- Trexima Study Presented at AAN Meeting
- FDA to Review “New” Migraine Drug
Last Updated on August 23, 2013 by Kerrie Smyres
