The potassium chloride oral solution was approved through the new approval pathway for drugs with no other approved competitors.
Several strengths of potassium chloride oral solution were approved by the US Food and Drug Administration today as the first generic drugs with a Competitive Generic Therapy designation. This new approval pathway aims to expedite the development and subsequent review of generic drugs for products that lack competition.
“Today’s approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition,” said FDA Commissioner Scott Gottlieb, MD.
Potassium chloride is indicated for the treatment and prevention of hypokalemia in patients taking diuretics, when dietary management using potassium-rich foods is inadequate or diuretic dose reduction is not feasible.
Under the FDA Reauthorization Act of 2017 (FDARA), the agency can designate a drug as a Competitive Generic Therapy (CGT) if there is inadequate generic competition for that drug—not more than 1 approved drug in the active section of the FDA’s Orange Book.
“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,” said Gottlieb. “So are our 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. This new generic drug application was also approved in its first cycle of review.”
Applicants for drugs designated as a Competitive Generic Therapy are eligible for review enhancements and expedited review of their Abbreviated New Drug Applications (ANDA). They also receive 180 days of marketing exclusivity if they are the first approved applicant for the CGT and meet certain other requirements.
The potassium chloride oral solutions approved today (potassium chloride oral solution USP, 10% (20 mEq/15 mL) and 20% (40 mEq/15 mL)) are eligible for the 180 days of exclusivity. The applying company, Apotex Inc., must commercially market them within 75 days of approval or forfeit exclusivity.
The most common side effects listed for the potassium chloride oral solution include nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea.
“This approval demonstrates that the competitive generic therapy pathway is efficient and open for business,” said Gottlieb. “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.”