FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals

Food and Drug Administration

WASHINGTON, D.C. — The following quote is attributed to Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research:

“This week, the FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation. This achievement highlights the success of the Competitive Generic Therapy program, which was designed to encourage the development and marketing of generic drugs for products with little to no competition.

There has been incredible interest in the Competitive Generic Therapy program since its inception in 2017; 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.

Additionally, more than 80% of the first-approved applicants who were eligible for Competitive Generic Therapy exclusivity started marketing the drug within 75 days after FDA approval. This is a sign the program is achieving what we hoped–spurring both development and market availability of safe and effective generic drugs in areas of the market that previously had little to no competition, giving patients more affordable access to medicine.”

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