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FDA Advisory Committee rejects Rexista (abuse-deterrent oxycodone hydrochloride extended release) to treat moderate to severe pain.-Intellipharmaceutics International Inc.

Read time: 1 mins
Last updated: 31st Jul 2017
Published: 31st Jul 2017
Source: Pharmawand

Intellipharmaceutics International Inc. announced that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA voted 22 to 1 in finding that the Company's New Drug Application for Rexista abuse-deterrent oxycodone hydrochloride extended release tablets should not be approved at this time.

The committees also voted 19 to 4 that the Company has not demonstrated that Rexista has properties that can be expected to deter abuse by the intravenous route of administration and 23 to 0 that there are not sufficient data for Rexista to support inclusion of language regarding abuse-deterrent properties in the product label for the intravenous route of administration.

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