Potassium Chloride Generics Approved Through New FDA Pathway
August 8, 2018 – The U.S. FDA has approved several strengths of generic potassium chloride oral solution through the Competitive Generic Therapy (CGT) designation pathway. These are the first generic drugs to receive the CGT designation.
Created in 2017, the CGT pathway is intended to speed the development and review of generics for off-patent drugs that lack competition. Products can enter the pathway only when no more than one approved drug exists under the “Active Section” of the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations document, commonly known as the Orange Book. CGT-designated drugs may be granted 180-day exclusivity if they meet certain conditions.
Potassium chloride oral solution first achieved FDA approval in 1948. It is indicated to treat or prevent hypokalemia (low potassium levels) in patients for whom dietary management with potassium-rich foods or diuretic dose reduction do not offer sufficient results. This latest FDA approval is for generic forms of the 10% (20 mEq/15 mL) and 20% (40 mEq/15 mL) strengths. Both strengths, which are manufactured by Apotex Inc., are eligible for 180 days of exclusivity, provided Apotex markets the products commercially within 75 days of approval.