Replies to post #27694 on Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

Rexista would not fill the gap left by taking Opana off the market.

Actually, an unsafe drug with shoddy ADF that causes great harm and toxicty- seems like Rexista would fill the gap left by Opana ER quite nicely.

I didnt read where they took off the original formula or this order will effect the original formula. In essence the way I read this while they may be forced to take the new version off the market what stops them from re-marketing the old version? It wasn't addressed. I can see this one being a lawyers gold mine

This is an interesting question. There are generic versions of original Opana ER that are still on the market. This FDA decision only applies to the reformulated ADF version, which, similar to Rexista, contains PEO as main ADF ingredient. Technically, Endo still holds the approved NDA for the original Opana ER, and they could go back to marketing it. But there's one big problem. In 2012, Endo delivered Citizen Petition to FDA requesting that the original version be declared unsafe. If it was removed for safety reasons, then it could not be listed as RLD for ANDA's. This is how Purdue prevented generic versions of original OxyContin. However, by 2012, there were already reports of widespread IV abuse of the reformulated Opana ER, and the FDA refused to do it. Not impossible, but it might present a significant challenge to market a drug that your own company tried to have declared unsafe. Like you said, a lawyers' gold mine.




http://freepdfhosting.com/512a49d841.pdf

CITIZEN PETITION

I. ACTION REQUESTED

Endo requests that FDA:

(1) Determine that the discontinued, non-crush-resistant version of Opana® ER
approved under NDA No. 021610 was discontinued for reasons of safety and can
no longer serve as an RLD for an ANDA applicant;