FDA Approves First Drug Under the Competitive Generic Therapy Pathway

Potassium chloride is an oral treatment indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.

Potassium Chloride Oral Solution 10% (20mEq/15mL) and 20% (40mEq/15mL) have become the first generic drugs to be approved under the Competitive Generic Therapy (CGT) approval pathway by the Food and Drug Administration (FDA). 

The generic approvals were granted to Apotex Inc.; the Company is eligible for 180 days of CGT exclusivity. Under a special forfeiture rule for CGTs, the applicant must commercially market the CGT within 75 days after the date of approval of its Abbreviated New Drug Application (ANDA) or it will forfeit its exclusivity.

Potassium Chloride is an oral solution indicated for the treatment and prevention of hypokalemia in patients who are taking diuretics, and when dietary management with K+-rich foods is insufficient or diuretic dose reduction is not possible. 

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The CGT program came into being following the FDA Reauthorization Act 2017 (FDARA) and is designed to reduce the number of review cycles that generic applications usually undergo. A drug can qualify for CGT designation if there is no more than 1 approved drug in the active section of the FDA’s Orange Book. Applicants for drugs with a CGT designation may receive enhanced and expedited review processes of their ANDA.

FDA commissioner Scott Gottlieb, MD, said in a statement, “The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs […] 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.”

For more information visit FDA.gov.