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. . ."]

3 comments:

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

http://fdatransparencyblog.fda.gov/

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

Do Watch!

Salmon

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!

Namaste

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.