Wednesday, June 26, 2019 6:11:23 PM
The link you provide is about IV drugs, so not relevant to this discussion. You might be confusing authorized generics. For example, Purdue actually does market an authorized generic version of OxyContin under their NDA, but that doesn't mean another company can do the same. If you are aware of any currently available tablet or capsule that was approved as NDA but is getting automatically substituted at the pharmacy as a generic for another NDA drug, please name it.
Yes, they did. They specifically have said that no new NDA's will be approved that are not as abuse deterrent as available products. For oxycodone ER, Xtampza sets the standard, not Oxycontin. Xtampza has the chewing label, so if FDA sticks to their published guidelines, no new NDA's for oxycodone ER will be approved without the chewing label.
I should revise what I said. The oxy ER will not be approved without an AdCom. No AdCom prior to PFUFA date for an opioid is typically not an indication of impending approval.
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