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Topic 574 - Dutasteride (Avolve / Duagen) - forum 24

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Re: Dutasteride

From: ButtGaser
Date: 6/2/2002
Time: 11:17:26 PM
Remote Name: 12.245.42.248

Comments

The sad truth is that no one knows exactly how long it usually takes for a typical sNDA to get approved. I've searched for a definitive answer and couldn't find anything conclusive, just that sNDA approval times vary. The FDA wouldn’t even comment on how long the Dutasteride sNDA might take, which really sucks because it's not like they'd be commenting on a drug that wasn't already approved. I couldn't find much information regarding sNDA's on the FDA's website. I guess it's because people just don't give a <edited> about sNDA's because drugs are usually marketed based purely on the NDA. The sNDA's are usually just a minor fluke, Glaxo sucks. However, I do understand why the FDA wouldn’t want to comment on a drug that is currently being reviewed and hasn't received an approval yet. It sucks that there has been all this controversy surrounding this on again, off again drug. It’s been one horror story after another with this drug not to mention all the problems with just getting the drug a damn trade name! Based on how many times Glaxo has screwed us, let’s not even get our hopes up when Dutasteride is approved because Glaxo will probably try everything to delay its being manufactured and distributed. Many drugs have gotten approved and marketed without so much difficulty! Why is this most important drug being screwed with time and time again!

-ButtGaser

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