First Generic Drug Under FDA's New Pathway for Enhancing Market Competition is Approved


The FDA has approved several strengths of Apotex Inc.’s potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy designation.

The FDA has approved several strengths of Apotex Inc.’s potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition.

Potassium chloride is an oral treatment that is indicated for the treatment and prevention of 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. The approved products include potassium chloride oral solution USP, 10% (20 mEq/15 mL); and 20% (40 mEq/15 mL))

In a prepared statement, FDA Commissioner Scott Gottlieb, MD, said the approval signifies the efficiency of a new program designed to encourage generic drug development for products with generic competition viewed as inadequate. “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. So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo,” said Gottlieb, in the statement. “This new generic drug application was also approved in its first cycle of review. 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.”

According to the FDA, a drug can be designated as a Competitive Generic Therapy if there is not more than 1 approved drug in the active section of the Orange Book. Applicants for drugs that receive a CGT designation may receive review enhancements and expedited review of their Abbreviated New Drug Applications (ANDA), and those applicants are eligible for a 180-day period of marketing exclusivity if they are the first approved applicant for that CGT, and meet certain other conditions.

Apotex's approved potassium chloride oral solution products are eligible for 180 days of CGT exclusivity. Under a special forfeiture rule for CGTs, the company must commercially market the CGT within 75 days after the date of approval of its ANDA or it will forfeit its exclusivity.

The approved potassium chloride products are intended for oral administration to patients. The most common adverse effects associated with the use of potassium chloride oral solutions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.

The agency requires ANDA applicants to demonstrate that all aspects of their drug product meet the FDA’s rigorous approval standards that ensure an equivalent, high quality, safe and effective generic medicine. As with brand-name drugs, the FDA reviews manufacturing, and packaging facilities for generic drugs to ensure they are capable of consistently producing quality products.


FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs [news release]. Silver Spring, MD; August 8, 2018; FDA website. Accessed August 8, 2018.

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