USA – FDA reaches milestone in generics approvals

The agency has approved more than 100 generic drugs with the competitive generic therapy designation since it launched the effort in 2017.

The Food and Drug Administration is marking progress in its efforts to bring more generics to market for products that have little or no generics available. The agency this past week noted that it has approved more than 100 medications under its competitive generic therapy designation.

“There has been incredible interest in the competitive generic therapy program since its inception in 2017,” said Sally Choe, director of the Office of Generic Drugs at the FDA’s Center for Drug Evaluation and Research. “Hundreds of applicants have requested competitive generic therapy designations, providing the ability for the FDA to approve more than 100 of these applications in less than four years, among a broad range of products and therapeutic areas…