FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

FDA approved on Wednesday several strengths of potassium chloride oral solution (Apotex), the first generic drugs to receive a Competitive Generic Therapy designation.

FDA approved on Wednesday several strengths of potassium chloride oral solution (Apotex), the first generic drugs to receive a Competitive Generic Therapy designation. Potassium chloride is indicated for the treatment and prevention of hypokalemia in patients who are on diuretics, and when dietary management with potassium-rich foods is inadequate or diuretic dose reduction is not possible. "Today's approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition," said FDA Commissioner Scott Gottlieb, MD. "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." According to Gottlieb, this new generic drug application was approved in its first cycle of review. Under new authorities provided to FDA in the FDA Reauthorization Act of 2017, a drug can be designated as a Competitive Generic Therapy if there is inadequate generic competition for that drug—that is, there is not more than one approved drug in the active section of the Orange Book.