FDA WARNING_LETTER - AB Science

The FDA Center for Veterinary Medicine (CVM) issued a Warning Letter to AB Science regarding promotional materials for Kinavet-CA1 (masitinib mesylate) found on its website and in submitted documents. The FDA determined these materials promote Kinavet-CA1 for unapproved new uses, lack adequate directions for use, omit critical effectiveness information, and minimize associated risks. Consequently, Kinavet-CA1 is deemed unsafe, adulterated, and misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act), violating 21 U.S.C. ?? 360b, 351(a)(5), 352(f), 331(a), 352(a), and 352(n). Specifically, the promotional content suggests Kinavet-CA1 is effective for a broader range of indications than its conditional approval for canine mast cell tumors, including canine atopic dermatitis, feline oncological/inflammatory diseases, and various other cancers and immune-mediated disorders. The letter emphasizes that extra-label use of conditionally approved drugs is prohibited. Furthermore, the materials fail to disclose that the drug's effectiveness has not been established and omit crucial human warning information and detailed adverse reactions for treated dogs, instead presenting the drug as "safe" and "generally well tolerated." These omissions and minimizations violate 21 CFR 202.1(e)(1) and 202.1(e)(6)(i). AB Science is required to immediately cease misbranding Kinavet-CA1 and introducing it into interstate commerce for unapproved uses. A written response detailing corrective actions, including discontinuing violative materials or ceasing drug distribution, is mandated within 15 calendar days. Failure to comply may lead to enforcement actions such as seizure and injunction.