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# Third Time a Charm? FDA Passes on Remoxy Panel Meeting
- URL: https://www.fdaweb.com/third-time-a-charm-fda-passes-on-remoxy-panel-meeting/
- Published: 2016-07-01T12:00:00.000Z
- Updated: 2026-09-14T21:12:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136102

FDA has told Pain Therapeutics that an advisory committee meeting for the third NDA submission for Remoxy (oxycodone), an extended-release capsule in an abuse-deterrent formulation for treating pain, is unnecessary and will not be held. The panel meeting had been tentatively scheduled for 8/5\. Remoxy was previously the subject of an advisory committee meeting in 2008, the company notes. The agency reportedly told the firm that NDA review remains active and on-going, and the user fee target data of 9/25 remains unchanged.

> The submission was made despite Pfizer deciding in 2014 to discontinue its agreement to develop and commercialize Remoxy due to unresolved issues outlined in a 2011 complete response letter from the agency. Pfizer said at the time that its decision was based on an “internal review of the top-line results of five recently completed clinical studies required to address the complete response letter...”  
>  
> A complete response letter was also sent in 2008 that asked for more non-clinical data to support the drug’s approval. That letter followed the advisory committee vote (11 to 8) recommending approval, although it said Remoxy’s label should say that it is tamper-resistant rather than the abuse-resistant statement the company wanted.