Determination That REVIA (Naltrexone Hydrochloride) Tablets, 50 mg Was Not Withdrawn From Sale for Safety or Effectiveness
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The FDA has confirmed that REVIA tablets, used for alcohol dependence and opioid effects blockade, were not pulled from shelves due to safety or effectiveness issues. As a result, the drug remains eligible for generic versions to be developed as long as they adhere to existing regulations.
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Key Changes
- FDA determined REVIA tablets were not withdrawn for safety or effectiveness reasons
- REVIA remains listed in the Orange Book for generic development
- Generic versions can continue to be approved if they meet standards
Obligations
What this law requires
ANDA applicants must submit their applications showing bioequivalence to the listed drug REVIA (naltrexone hydrochloride) tablets, 50 mg.
Companies seeking to produce generic versions of Revia (naltrexone hydrochloride) must comply with existing legal and regulatory requirements for Abbreviated New Drug Applications (ANDAs).
FDA must continue to list REVIA (naltrexone hydrochloride) tablets, 50 mg, in the 'Discontinued Drug Product List' section of the Orange Book.
ANDA applicants for Revia (naltrexone hydrochloride) must show that their product has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and labeling as the listed drug.
ANDA applicants must demonstrate that their generic version of Revia is bioequivalent to the listed drug.