FDA has approved oxycodone hydrochloride and naltrexone hydrochloride (Troxyca ER—Pfizer) extended-release capsules, for oral use, CII for the management of pain severe enough to require daily, long-term opioid treatment. The drug is the only oxycodone with oral abuse-deterrent features described in the labeling.
The FDA has given the nod to Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride, Pfizer) extended-release capsules for oral use (CII) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
NORTHVALE, N.J., Dec. 3, 2014 (GLOBE NEWSWIRE) — Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCBB:ELTP) announced today successful results from a pivotal bioequivalence (BE) study for ELI-201, Elite’s twice daily abuse-deterrent oxycodone product which utilizes Elite’s proprietary pharmacological abuse-deterrent technology.
The study, initiated in July of 2014, demonstrated Elite’s product is bioequivalent (more…)