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Post# of 253280
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Re: None

Tuesday, 08/10/2010 6:26:47 PM

Tuesday, August 10, 2010 6:26:47 PM

Post# of 253280
TEVA: In light of the "Teva/FDA labeling discussions" remark from @ 6 months ago, I am wondering the following:

1. Teva has a non-AB rated generic approvable by the FDA, however
2. Teva is arguing with the FDA back and forth to upgrade to AB-rated
3. Teva is not willing to bother with a launch of a non-AB version due to a perceived lack of meaningful revenues.
4. If the FDA does not agree with Teva, they may quietly withdraw the aNDA.
5. Teva has no leverage since they need the FDA to approve their other 200 or so pending applications.
6. Or, obviously, the FDA is outright refusing to approve anything other than AB-rated due to patient safety.

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-Dan Quayle

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