First generic approved under FDA pathway to foster competition

FDA approved the first generic drug under a new pathway aimed at curbing prices of generic drugs that have no competitor. The inaugural approval went to Apotex Inc. (Toronto, Ontario) for its potassium chloride oral solution to treat hypokalemia.

Established under the FDA Reauthorization Act of 2017 (FDARA), the Competitive Generic Therapy (CGT) pathway offers expedited review of an ANDA if there is only one other approved generic version of the product in the Orange Book...