First drug approved under streamlined generic approval process

The first medication approved by FDA as part of an expedited generic drug program is one that has been in short supply in U.S. hospitals.

Potassium chloride oral solution, used to treat and prevent hypokalemia (low potassium blood levels) in patients who are on diuretics, is consistently on FDA’s Drug Shortages list.

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Apotex received the okay for generic potassium chloride injection under FDA’s Competitive Generic Therapy (CGT) designation, a new approval pathway created to expedite the development and review of a generic drug for products that lack competition.

“The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs,” said FDA Commissioner Scott Gottlieb, MD, in a statement.

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The FDA Reauthorization Act of 2017 (FDARA), signed into law in August, 2017, amended the Federal Food, Drug, and Cosmetic Act to establish a new process to designate, and expedite the development and review of, certain drugs for which there is inadequate generic competition.

“It also created a new type of 180-day exclusivity for the first approved applicant of a drug with a Competitive Generic Therapy (CGT) designation for which there were no unexpired patents or exclusivities listed in the Orange Book at the time of original submission of the ANDA. These new provisions provide incentives for efficient review and timely market entry of drugs for which there is inadequate generic competition,” Kristofer Baumgartner, an FDA spokesperson, told FormularyWatch.

Generic potassium chloride was approved in its first cycle of review. “This approval demonstrates that the competitive generic therapy pathway is efficient and open for business. This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need,” Gottlieb said.

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