Replies to post #339173 on Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

it’s the fatty meal issue not anything about bioequivalence, so far as i know.

The fatty meal issue and the bioequivalence issue are the exact same issue. Zombie SequestOx was never bioequivalent. As my previous research proved, the FDA never paid any attention to FED pharmacokinetics for ANDA (generic) oxycodone. Not a labeling issue but rather just didn't pay attention to it. But NDA's are different. Purdue had just gone down in flames at AdComm for their ADF oxy IR because of the exact same issue, lack of FED bioequivalence.