FDA Confirms REVIA Withdrawal Not Due to Safety Issues
Published Date: 4/16/2026
Notice
Summary
The FDA has decided that REVIA (naltrexone hydrochloride) 50 mg tablets were not taken off the market because of safety or effectiveness problems. This means generic drug makers can keep getting approval to sell their versions of REVIA, keeping options open for patients and pharmacies. No changes in safety rules or extra costs are expected, so everyone can breathe easy and keep using or making this medicine.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Generic Approvals Can Continue
The FDA found that REVIA (naltrexone hydrochloride) 50 mg tablets were not withdrawn for safety or effectiveness, so the Agency will continue to approve abbreviated new drug applications (ANDAs) that refer to this product as long as they meet legal and regulatory requirements. This determination was published April 16, 2026 and applies to REVIA NDA 018932 (initially approved November 20, 1984).
Existing ANDAs Won't Be Withdrawn
FDA will not begin procedures to withdraw approval of any approved ANDAs that refer to REVIA (naltrexone hydrochloride) 50 mg. That protection follows FDA's determination under 21 CFR 314.161 that the product was not withdrawn for safety or effectiveness.
Product Remains Discontinued, Labeling Note
FDA will continue to list REVIA (naltrexone hydrochloride) 50 mg in the Orange Book's "Discontinued Drug Product List," indicating it was discontinued for reasons other than safety or effectiveness. If FDA determines that labeling should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
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