www.fdanews.com/articles/100577-pozen-8217-s-amended-response-for-trexima-accepted-by-fda
Pozen’s Amended Response for Trexima Accepted by FDA
November 2, 2007
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.