Teva To Submit Third Abuse-Deterrent Hydrocodone NDA By End Of 2014

Teva Pharmaceuticals this month initiated a rolling New Drug Application submission to FDA for an abuse-deterrent pure hydrocodone tablet, making it the third company in the race to bring such a product to market. Richard Malamut, vice president of global clinical development at Teva, told FDA Week that the drug was developed according FDA draft guidance on abuse-deterrent formulations. Malamut said Teva completed studies in all of the categories FDA recommends in the draft guidance, as well as the human...