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Remoxy Approval Status

Remoxy ER (oxycodone) is a long-acting abuse-resistant narcotic analgesic formulation in development for the treatment of moderate to severe chronic pain.

On September 26, 2016, Pain Therapeutics, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on the resubmission of its new drug application (NDA) for Remoxy ER (oxycodone capsules CII). The CRL identified further actions and studies required to obtain approval of Remoxy ER with label claims on three routes of abuse (injection, inhalation and snorting).

Development Status and FDA Approval Process for Remoxy

Sep 26, 2016Pain Therapeutics Receives Complete Response Letter for Remoxy ER
Apr 12, 2016FDA Accepts Remoxy NDA for Review
Mar 29, 2016Pain Therapeutics Resubmits Remoxy New Drug Application to the U.S. Food and Drug Administration
Oct 27, 2014Pfizer to Discontinue Agreement on Remoxy (oxycodone) Extended-Release Capsules CII
Jun 24, 2011FDA Complete Response Letter Received for Remoxy
Jan 27, 2011Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011
Dec 27, 2010King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for Remoxy
Dec 11, 2008Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy
Jun 10, 2008Pain Therapeutics and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy

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