Watson received FDA approval for a generic version of Plan B, Duramed Pharmaceuticals’ emergency contraceptive. Watson’s generic is approved for prescription only, in women 17 and younger. Duramed retains OTC exclusivity on the product – indicated for women 18 years and older – until August 24, 2009.
FDA did not approve GlaxoSmithKline‘s Rexonic (casopitant mesylate), an antiemetic. FDA issued a complete response letter containing questions that “preclude the approval of the application,” according to a GSK statement. “[GSK] is reviewing this letter and will engage FDA to determine appropriate next steps,” the statement said.
