Bimeda, Inc. – FDA Warning Letter

The FDA Center for Veterinary Medicine (CVM) issued a Warning Letter to Bimeda, Inc. regarding an advertisement for OVAMED (altrenogest) Solution 0.22% in "The Practitioner" (Issue 3-2017). The advertisement, submitted to FDA on October 10, 2017, was deemed false or misleading due to the omission of important risk information, creating a misleading impression about the drug's safety for human handlers. This misbranding violates sections 352(n) and 321(n) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and its introduction into interstate commerce violates section 301(a).

OVAMED is indicated to suppress estrus in mares. The FDA-approved labeling includes extensive human warnings: it is readily absorbed through unbroken skin, requiring protective gloves. Pregnant women or those who suspect pregnancy, and women of child-bearing age, should avoid handling it due to risks like menstrual cycle disruption or prolonged pregnancy. The product also lists specific individuals who should not handle it, including those with thrombophlebitis, cerebral-vascular disease, certain cancers, undiagnosed vaginal bleeding, liver dysfunction, or tumors developed from oral contraceptives. Accidental exposure requires immediate washing with soap and water for skin contact, flushing with water for eye contact, and physician consultation if swallowed due to the oil base.

The violative advertisement included