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# Buprenex Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/buprenex-not-withdrawn-due-to-safety-efficacy/
- Published: 2023-11-22T12:00:00.000Z
- Updated: 2026-09-14T14:16:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155848

*Federal Register* notice: FDA has determined that Indivior’s Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Buprenex is indicated for managing pain severe enough to require an opioid analgesic and alternative treatments are inadequate. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-22/pdf/2023-25857.pdf?ref=fdaweb.com).