Intellipharmaceutics International Inc. (IPCI)

[numbersarefun]

WeeZuhl, Oxycodone ER is generic chemical name. 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

WeeZuhl wrote: "As a result, their drug will need to prove abuse deterrence as good as all other NDA's, which means it will need a successful chewing study."

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?

WeeZuhl wrote: "There most definitely will be an AdCom in order to discuss the nasal and chewing HAL studies, which were notably absent at AdCom #1."

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.