Home » Pozen’s Amended Response for Trexima Accepted by FDA
Pozen’s Amended Response for Trexima Accepted by FDA
The FDA has accepted Pozen’s amended response to the Aug. 1 approvable letter for Trexima.
The agency said it considers the submission to be a complete Class II response, which could result in a new decision date of April 15, 2008.
Pozen has development and commercialization alliances with GlaxoSmithKline for Trexima, which combines sumatriptan and naproxen sodium in a single tablet for the acute treatment of migraine, Pozen said.
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