FDA Greenlights Generic Party for Addiction Treatment Drug REVIA
Published Date: 4/16/2026
Notice
Summary
The FDA has decided that REVIA (naltrexone hydrochloride) 50 mg tablets weren’t 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, helping patients access affordable options. No changes in safety rules or extra costs are expected, so things stay steady for doctors, patients, and pharmacies.
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Analyzed Economic Effects
4 provisions identified: 3 benefits, 0 costs, 1 mixed.
Generic Approvals Can Continue
On April 16, 2026, FDA determined that REVIA (naltrexone hydrochloride) 50 mg was not withdrawn from sale for reasons of safety or effectiveness. Because of that decision, FDA will continue to approve abbreviated new drug applications (ANDAs) that refer to REVIA as long as those ANDA applicants meet legal and regulatory requirements. This helps generic drug makers keep seeking approvals and can help patients access more affordable versions of REVIA.
Existing ANDA Approvals Preserved
FDA will not begin procedures to withdraw approval of any already-approved ANDAs that refer to REVIA (naltrexone hydrochloride) 50 mg. That means companies holding approved generic versions that reference REVIA keep their approvals in place rather than facing withdrawal procedures.
REVIA Remains in Orange Book Discontinued List
FDA will continue to list REVIA (naltrexone hydrochloride) 50 mg in the Orange Book’s "Discontinued Drug Product List," showing it was discontinued for reasons other than safety or effectiveness. The listing reflects that the NDA (018932) was withdrawn at the request of the sponsor and does not signal a safety or effectiveness problem.
Possible Labeling Updates for Generics
FDA said that if it determines labeling for REVIA should be revised to meet current standards, the Agency will advise ANDA applicants to submit updated labeling. That means future generic applicants may be asked to use revised labeling to match current regulatory expectations.
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