FDA Approves First Generic Methimazole Coated Tablets for Treating Hyperthyroidism in Cats
July 22, 2025
The U.S. Food and Drug Administration has approved Methimazole Coated Tablets, the first FDA-approved generic version of methimazole tablets for the treatment of hyperthyroidism in cats.
FDA advises veterinarians and pet owners that unlike unapproved “generic” tablets marketed online, the recently approved Methimazole Coated Tablets (ANADA 200-814) has been evaluated by the FDA to ensure the product is bioequivalent to the pioneer product, Felimazole (NADA 141-292). The FDA approved in May 2009 after reviewing product safety, effectiveness, and adequacy of the manufacturing process.
Methimazole Coated Tablets are only available by prescription from a licensed veterinarian because professional veterinary expertise is needed to diagnose hyperthyroidism in cats and to determine whether Methimazole Coated Tablets are an appropriate treatment. Continued veterinary monitoring is also needed to ensure that the dose continues to be appropriate to control the cat’s hyperthyroidism, as this disease can progress over time.
Methimazole Coated Tablets are supplied in 2.5 mg and 5 mg for oral administration. Methimazole Coated Tablets are dosed in 2.5 mg increments, every 12 hours. Dose adjustments should be made in 2.5 mg increments. The maximum total dosage is 20 mg per day divided, not to exceed 10 mg as a single administration.
People administering Methimazole Coated Tablets should wash their hands with soap and water after administration to avoid exposure to the drug.
Methimazole Coated Tablets are sponsored by Felix Pharmaceuticals Pvt. Ltd. Based in Ireland.
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