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# FDA Approves a Valeant Pharma NDA for Relistor Tablets
- URL: https://www.fdaweb.com/fda-approves-a-valeant-pharma-nda-for-relistor-tablets/
- Published: 2016-07-20T12:00:00.000Z
- Updated: 2026-09-14T21:15:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136241

FDA has approved a Valeant Pharmaceuticals and Progenics Pharmaceuticals NDA for Relistor (methylnaltrexone bromide) tablets for treating opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Relistor subcutaneous injection (12 mg and 8 mg) was approved in 2008 for treating OIC in adults with advanced illness who are receiving palliative care and in 2014 for treating OIC in adults with chronic non-cancer pain. Approval was based on data from a Phase 3 trial that showed methylnaltrexone-treated patients demonstrated statistically significant improvements in rescue-free bowel movement (RFBM) within 4 hours of administration over 28 days of dosing when compared to placebo treatment, which was the primary endpoint.