Remoxy ER 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 Status and FDA Approval Process for Remoxy ER
|Feb 5, 2019||Pain Therapeutics Announces Feedback from Recent Meeting With FDA on Remoxy|
|Aug 6, 2018||Complete Response Letter Issued for Remoxy|
|Jun 26, 2018||Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for Remoxy ER|
|Mar 1, 2018||FDA Accepts Remoxy NDA For Review|
|Feb 13, 2018||Pain Therapeutics Resubmits New Drug Application for Remoxy ER, an Abuse-Deterrent, Extended-Release Drug Candidate for the Treatment of Chronic Pain|
|Sep 26, 2016||Pain Therapeutics Receives Complete Response Letter for Remoxy ER|
|Apr 12, 2016||FDA Accepts Remoxy NDA for Review|
|Mar 29, 2016||Pain Therapeutics Resubmits Remoxy New Drug Application to the U.S. Food and Drug Administration|
|Oct 27, 2014||Pfizer to Discontinue Agreement on Remoxy (oxycodone) Extended-Release Capsules CII|
|Jun 24, 2011||FDA Complete Response Letter Received for Remoxy|
|Jan 27, 2011||Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011|
|Dec 27, 2010||King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for Remoxy|
|Dec 11, 2008||Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy|
|Jun 10, 2008||Pain Therapeutics and King Pharmaceuticals Announce Submission of
New Drug Application for Remoxy|
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