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  1. FDA In Brief

FDA In Brief: FDA Finalizes Guidance for Industry on Applications for Drugs with Inadequate Generic Competition

March 13, 2020

Media Inquiries

  Jim McKinney
  240-328-7305

The following quote is attributed to FDA Commissioner Stephen M. Hahn, M.D.:

“Increased competition empowers patients with more choices for their health care. By providing incentives for the development of generic versions of drugs that currently face little or no competition, we are better able to foster the development of more safe and effective generic drugs, which we expect will result in increased access to necessary treatments and potentially lower the cost of these medications.

“In particular, the competitive generic therapy, CGT, designation has been a significant advancement in helping to bolster generic drug competition in the U.S. Since Congress provided us with this authority, we have received more than 350 CGT requests from drug manufacturers and have approved a number of products with this designation.

“The finalization of guidance on CGTs underscores our commitment to encouraging generic entry for drugs that face inadequate competition – a key part of our Drug Competition Action Plan.”

  • Today, the U.S. Food and Drug Administration finalized guidance for industry, “Competitive Generic Therapies” (CGTs), which describes the process that generic drug applicants should follow to request designation of a drug as a CGT and the criteria for that designation.
  • The final guidance provides information on actions the FDA may take to expedite development and review of Abbreviated New Drug Applications (ANDAs) for drugs designated as CGTs and explains how the FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first-approved applicants who submit ANDAs for CGTs.
  • This final guidance was first published as a draft in Feb. 2019 following the FDA Reauthorization Act of 2017, which amended the Federal Food, Drug and Cosmetic Act to add new provisions related to CGTs.
  • The FDA recently published a new webpage listing all approved ANDAs for products that received a CGT designation. The list is updated on a bi-weekly basis and includes information about the approved application, drug product and any potential CGT exclusivity .

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products..