Determination That REVIA (Naltrexone Hydrochloride) Tablets, 50 Milligrams Was Not Withdra
The Food and Drug Administration (FDA or Agency) has determined that REVIA (naltrexone hydrochloride) tablets, 50 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (AN
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-04-16 |
| Summary | The Food and Drug Administration (FDA or Agency) has determined that REVIA (naltrexone hydrochloride) tablets, 50 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. |
| Document number | 2026-07451 |
| Official record | https://www.federalregister.gov/documents/2026/04/16/2026-07451/determination-that-revia-naltrexone-hydrochloride-tablets-50-milligrams-was-not-withdrawn-from-sale |