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# Don’t Approve Remoxy ER NDA: PMRS
- URL: https://www.fdaweb.com/dont-approve-remoxy-er-nda-pmrs/
- Published: 2018-07-24T12:00:00.000Z
- Updated: 2026-09-15T00:21:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141947

Pharmaceutical Manufacturing Research Services (PMRS) is asking FDA not to approve any pending or future application for a section 505(b) or 505(j) opioid product with a proposed indication or any other labeling that suggests that the product is appropriate for chronic use. PMRS asks that its requests be applied specifically to the Pain Therapeutics Remoxy ER NDA as well as all other pending and future applications. It notes that it submitted an NDA 1/16/17 for oxycodone HCI IR ADF capsules with a proposed indication for managing acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

“The root cause of the United States opioid epidemic is FDA’s approval of opioid drug products for the treatment of chronic pain absent substantial evidence of efficacy,” PMRS says. “Exacerbating the problem, the FDA-approved labeling provided the medical community with false reassurance that opioids are safe and effective in the treatment of chronic pain despite a lack of evidence to support such an indication.” PMRS says its requested action on any pending or future specified opioid NDA would address its concerns.