The Federal Drug Authority (FDA) announced the first Competitive Generic Therapy (CGT)-designated abbreviated new drug application (ANDA), also known as a generic drug application, which was approved on August 8, 2018. The related guidance for industry, Competitive Generic Therapies, was published as a draft in February 2019 and finalized in March 2020. This week, the FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation.
The guidance 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.
At the request of the ANDA applicant, the FDA may take steps to expedite the development and review of ANDAs for drugs that receive a CGT designation. These actions can include product development or pre-submission meetings with the agency to discuss scientific issues or questions, or the format and content of a future ANDA, as well as mid-review-cycle meetings regarding any issues identified during the FDA’s review.
Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research commented that, “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.” She went on to say that 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.
The CGT program is part of the FDA Drug Competition Action Plan, which seeks to foster generic competition and help address the high cost of drugs.
