The FDA approved Evita Solutions’ abbreviated new drug application for mifepristone 200 mg tablets, with the approval taking effect Sept. 30.
The product was determined to be bioequivalent and therapeutically equivalent to Danco Laboratories’ Mifeprex 200 mg tablets, according to a Sept. 30 approval letter. Evita’s ANDA, originally submitted Oct. 1, 2021, was approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act, which permits the agency to approve an ANDA with labeling that temporarily differs from that of the reference listed drug when certain changes to the labeling for the RLD have recently been approved. The drug is indicated for the medical termination of intrauterine pregnancy through 70 days’ gestation.
Evita’s product will be included in the Mifepristone REMS program, a single, shared system that includes elements to assure safe use and an implementation system. The company’s final proposed REMS, submitted April 16, was approved.
The FDA said Evita’s REMS must be fully operational before the drug can be introduced into interstate commerce.
