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Wednesday, January 11, 2023 2:14:01 PM
"Regarding the ADT for OxyContin, we filed that product and then after we finished the clinical trials, passed the clinical trials performed the in vitro, which took about a year of seeing that it cannot be abused by household products, and we filed it with FDA as did everybody in the industry. Well, Purdue was successful in convincing the FDA that everybody needs to go back and do an anti-abuse study, which is in insufflations, i.e. snort OxyContin and snort this product and show that they’re effective. And that’s where everybody stopped. If you have noticed, nobody has gotten an approval for a generic OxyContin. So, that is the study that is needed before we re-file this product."
June 30, 2022:
"As was announced, we are working on Oxy ER. We have to do certain studies that will be concluded by Q1 of 2023."
August 16, 2022:
"No one has entered the market yet to compete with Oxycodone as a generic. Couple of companies made a brand new products, but nobody has done that. And that's because, of course, Purdue had a ton of patents and they went back to FDA and changed their regulations and asked for more clinical trials and quite a few other things. So we are running the last set of clinical trials that we believe the regulations calls for today. Well, actually that the regulations does call for today, okay? And we hope that we could file by Q2 of 2023.
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