Posted by Michael Wonder on 04 Feb 2017
Intellipharmaceutics announces FDA acceptance for filing of NDA for Rexista (oxycodone hydrochloride extended release), an abuse deterrent opioid analgesic for the treatment of moderate to severe pain
2 February 2017 - Intellipharmaceutics International today announced that the U.S. FDA has accepted for filing the company's previously-announced new drug application seeking authorisation to market its Rexista abuse-deterrent oxycodone hydrochloride extended release tablets in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
The FDA has determined that the company's application is sufficiently complete to permit a substantive review, and has set a target action date under the Prescription Drug User Fee Act of 25 September 2017.
