The U.S. Food and Drug Administration has reached the milestone of announcing the approval of more than generic drug applications, the agency announced Thursday.
“This week, the FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy (CGT) designation,” said Dr. Sally Choe, Director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.
“This achievement highlights the success of the Competitive Generic Therapy program,” she added, “which was designed to encourage the development and marketing of generic drugs for products with little to no competition.”
The FDA approved CGT-designated abbreviated new drug application (ANDA), also called a generic drug application, on August 8, 2018.
The CGT-related guidance, which was published as a draft in February 2019 and then finalized in March 2020, describes the process that generic drug applicants should follow to request designation of a drug as a CGT and the criteria for that designation, as well as additional information about the CGT program, according to the FDA.
Dr. Choe said, “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.”
The CGT program, which is part of the FDA Drug Competition Action Plan, seeks to foster generic drug competition and address the high-priced brand-name drugs.
“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,” Dr. Choe said.
“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,” she added. The news was announced Thursday on the FDA’s official website.
