Product News

Share this article:
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.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Channel

 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.