Apotex breaks ground on new FDA generics track

Apotex's potassium chloride has become the first generic drug to be granted Competitive Generic Therapy designation by the US Food and Drug Administration (FDA).

The new designation is designed to expedite the approval process for certain generic drugs, in accordance with FDA Commissioner Scott Gottlieb's longstanding push for increased access to generic and biosimilar therapies.

A drug may receieve the designation if there is only one equivalent therapy already FDA-approved, or if there are none at all. In the case of a generic product being first to market, meeting certain conditions may result in the FDA granting the manufacturer 180 days of market exclusivity. Apotex's potassium chloride has been granted exclusivity, but if it has not launched within 75 days of its approval it will forfeit that privilege.