Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

An 505(b)2 NDA can be marketed as generic, in addition to name brand, if the FDA gives it a TE Code of AB. Since company is just calling the drug "Oxycodone ER", I assume that is the path IPCIF is seeking. If you look up an NDA there is a column for "TE Code" and Therapeutic Equivalents for NDA are listed at the bottom.

Camargo says there are AB Rated 505(b)(2) NDAs:
https://camargopharma.com/resources/blog/ab-rated-505b2s

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.

I assume FDA gives guidance on what abuse studies were required after the 1st AdCom. Did FDA say they needed a "successful chewing study" to get approved?

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 was just guessing no Advisory Committee meeting, since I have not heard of one scheduled yet. Does not FDA need to give company time to prepare for an Adcom and time for FDA to consider Adcom advice? IPCIF's 1st AdCom was announced about a month before the meeting and was scheduled about 2 months before PDUFA. It is getting too late to 2nd PDUFA date to schedule an AdCom.

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.