Print Ad Misbrands Seizure Drug Aptiom, FDA Says in ‘Untitled’ Letter

A print advertisement for the seizure drug Aptiom (eslicarbazepine acetate) is misleading because it overstates the efficacy of the drug, the Food and Drug Administration said in a letter posted recently online.

The Dec. 15 “untitled letter” from the agency, sent to Sunovion Pharmaceuticals Inc. in Marlborough, Mass., said the FDA’s Office of Prescription Drug Promotion (OPDP) reviewed the print advertisement. The agency said the print advertisement misbrands Aptiom within the meaning of the Federal Food, Drug, and Cosmetic Act, which makes its distribution violative.

Aptiom is indicated as adjunctive treatment of partial-onset seizures, the letter said. It is associated ...