FDA approves generic drug for managing allergic dermatitis in cats

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Officials with the FDA have approved Modulis for Cats, the first generic cyclosporine oral solution for companion felines, by Provetica LLC. It contains the same active ingredient in the same concentration and dosage form as the Atopica for Cats brand product by Elanco.

Cyclosporine oral solution for cats is indicated for the control of certain skin conditions resulting from feline allergic dermatitis. Cats with feline allergic dermatitis may be intensely itchy and lick, chew and scratch at their skin and hair. As a result, affected cats can develop excoriations because of the cat scratching itself, miliary dermatitis, skin lesions, and self-induced hair loss.

Modulis for Cats is an immunosuppressant drug that suppresses the allergic process that causes cats with this condition to be itchy. The drug is intended for use in cats at least 6 months of age and at least 3 lbs in body weight. It is supplied in 4.7-, 15-, and 30-mL glass amber bottles and is only available by prescription from a licensed veterinarian.

People handling, administering, or exposed to cyclosporine oral solution for cats should take precautions to avoid accidentally ingesting the drug, such as not eating, drinking, smoking or using smokeless tobacco while handling it, according to the FDA. Users should also wash hands after administration of this product. People with known hypersensitivity to cyclosporine should avoid contact with the product.

Atopica for Cats was first approved by the FDA on August 8, 2011.

Reference

FDA approves first generic cyclosporine oral solution for cats for treatment of allergic dermatitis. News release. FDA. March 29, 2023. Accessed March 29, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-cyclosporine-oral-solution-cats-treatment-allergic-dermatitis?utm_medium=email&utm_source=govdelivery