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. . ."]


Anonymous said...

Speaking of the FDA tomorrow the FDA is holding a meeting on Transparency and is having a number of people give comments. It should be 'very' interesting. According to the FDA transparency blog website


it is supposed to be webcast although they haven't posted any details yet.

Do Watch!


Condor said...

Thanks Salmon! -- I wouldn't miss it for the world.

I'll likely offer some thoughts on it, end of day, tomorrow. . . . would welcome your take on it, too!


Anonymous said...

Those who cannot attend the meeting can view the event via live Webcast at: www.fda.gov/transwebcast_june09. After the meeting, the Webcast will be available for viewing at the same link.