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
| Date | Article |
|---|
| 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 |
Further information
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