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Remoxy ER FDA Approval Status

FDA Approved: No
Brand name: Remoxy ER
Generic name: oxycodone
Company: Pain Therapeutics, Inc.
Treatment for: Pain

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

Development timeline for Remoxy ER

DateArticle
Feb  5, 2019Pain Therapeutics Announces Feedback from Recent Meeting With FDA on Remoxy
Aug  6, 2018Complete Response Letter Issued for Remoxy
Jun 26, 2018Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for Remoxy ER
Mar  1, 2018FDA Accepts Remoxy NDA For Review
Feb 13, 2018Pain Therapeutics Resubmits New Drug Application for Remoxy ER, an Abuse-Deterrent, Extended-Release Drug Candidate for the Treatment of Chronic Pain
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

Further information

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