FDA Grants First Approvals Via the Competitive Generic Therapy Pathway

The FDA approved drug products under the Competitive Generic Therapy (CGT) designation for the first time, granting approval to several strengths of Apotex’s potassium chloride oral solution.

The drug is indicated for treating and preventing low potassium blood levels in patients taking diuretics and when treatment through dietary management is insufficient or the diuretic dose cannot be reduced.

“This approval demonstrates that the CGT pathway is efficient and open for business,” said FDA Commissioner Scott Gottlieb. He described the pathway as “a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition” to make treatments affordable.