1:54 PM
Aug 08, 2018
 |  BC Extra  |  Politics & Policy

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.

FDA Commissioner Scott Gottlieb said, "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 added that Wednesday's approval also highlights FDA's "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." FDA approved Apotex's ANDA in its first review cycle.

The first product approved for each CGT designation is eligible for 180 days market exclusivity as long as it is commercially launched within 75 days of approval.

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