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

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.”

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