FDA Approves First Fast-Track Generic

The FDA approved several strengths of potassium chloride oral solution, the first generic drugs approved under an expedited generic drug program.

Potassium chloride, which is consistently on FDA’s Drug Shortages list,  is used to treat and prevent hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.

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.

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“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,” says FDA Commissioner Scott Gottlieb, MD, in a statement.

Thirty-three new drug applications were awaiting FDA action in the second quarter of fiscal year 2018 as part of the CGT program, according to a quarterly FDA report.

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, tells Drug Topics.

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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 says.

The potassium chloride oral solution products approved are eligible for 180 days of CGT exclusivity. “Under a special forfeiture rule for CGTs, the applicant must commercially market the CGT within 75 days after the date of approval of its ANDA or it will forfeit its exclusivity,” FDA says in the statement.