Showing posts with label OTC Zegerid December 2009 FDA Action Delayed June 23 2009. Show all posts
Showing posts with label OTC Zegerid December 2009 FDA Action Delayed June 23 2009. Show all posts

Tuesday, June 23, 2009

No FDA Approval of OTC Version of Zegerid Until Year-End 2009. . . .


This is waifish, especially when compared to the pro-forma revenues of the to-be-combined companies, but worthy of note, nonetheless -- as it may be the way things go, generally, at FDA for Schering-Plough, for the foreseeable future.

MarketWatch has the scoop, this morning:

. . . .The Food and Drug Administration said it would act in December 2009 on Schering-Plough HealthCare Products' new-drug application to market an over-the-counter version of Zegerid, a treatment for heartburn. . . .

Indeed. The NDA was filed in March of 2008, so that's at least a one-and-three-quarters years-long timeline. And that's very-nearly a "slow roll". . . .

[Meanwhile, ". . .The Little Engine puffed "I think I can, I think I can, I think I can. . ."]