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Panel rejects Rexista abuse deterrence claims
July 27, 2017 12:19 AM UTC
FDA’s Anesthetic and Analgesic Drug Products and Drug Safety & Risk Management Advisory Committees voted 22-1 against approval of Rexista oxycodone XR from Intellipharmaceutics International Inc. (TSX:IPCI; NASDAQ:IPCI), and voted 23-0 that available data were insufficient to support claims of abuse deterrence on its label.
FDA is reviewing an NDA for Rexista to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Rexista’s PDUFA date is Sept. 25...
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