FDA Approves First Generic Cyclosporine Oral Solution for Cats for Treatment of Allergic Dermatitis

March 29, 2023

Today, the U.S. Food and Drug Administration approved Modulis for Cats, the first generic cyclosporine oral solution for cats. Modulis for Cats is indicated for the control of certain skin conditions resulting from a disease called 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 (due to the cat scratching itself), miliary dermatitis (a skin condition in cats that most commonly is due to allergic reaction), eosinophilic plaques (skin lesions), and self-induced alopecia (hair loss). 

Modulis for Cats is an immunosuppressant drug that suppresses the allergic process that causes cats with this condition to be itchy. It contains the same active ingredient (cyclosporine) in the same concentration and dosage form as the approved brand name drug product, Atopica for Cats, which was first approved on August 8, 2011. 

Modulis for Cats is intended for use in cats at least 6 months of age and at least 3 lbs (1.4 kg) in body weight. It is only available by prescription from a licensed veterinarian because professional veterinary expertise is needed to diagnose feline allergic dermatitis and determine whether Modulis for Cats is an appropriate treatment. 

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

Modulis for Cats is supplied in 4.7, 15, and 30 mL glass amber bottles.

Modulis for Cats is sponsored by Provetica, LLC, based in Lenexa, Kansas.

100ml PP vaccine vial

250ml PE plastic vaccine bottle

Source from FDA: https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-cyclosporine-oral-solution-cats-treatment-allergic-dermatitis