FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

FDA News Release

• For Immediate Release: August 08, 2018

The U.S. Food and Drug Administration today approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment that is 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.

“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, M.D. “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. 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. This approval demonstrates that the competitive generic therapy pathway is efficient and open for business. 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.”

Under new authorities provided to the agency in the FDA Reauthorization Act of 2017 (FDARA), a drug can be designated as a Competitive Generic Therapy if there is inadequate generic competition for that drug, meaning there is not more than one approved drug in the active section of the Orange Book. Applicants for drugs that receive a CGT designation may receive review enhancements and expedited review of their Abbreviated New Drug Applications (ANDA). Applicants for drugs that receive a CGT designation are also eligible for a 180-day period of marketing exclusivity if they are the first approved applicant for that CGT and meet certain other conditions. The potassium chloride oral solution products approved today (potassium chloride oral solution USP, 10% (20 mEq/15 mL) and 20% (40 mEq/15 mL)) are 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 ANDA or it will forfeit its exclusivity.

Hypokalemia is a condition in which the amount of potassium in the blood is lower than normal. Proper potassium levels are necessary for cells within the body to function properly. Low potassium levels can lead to abnormal heart rhythms, especially in people with heart disease, as well as lightheadedness, fainting or, in extreme cases, heart failure paralysis or even death.

Potassium chloride oral solution is intended for oral administration to patients. The most common side effects associated with its use are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea.

The agency requires ANDA applicants to demonstrate that all aspects of their drug product meet the FDA’s rigorous approval standards that ensure an equivalent, high quality, safe and effective generic medicine. As with brand-name drugs, the FDA reviews manufacturing and packaging facilities for generic drugs to ensure they are capable of consistently producing quality products.

The FDA granted approval of potassium chloride oral solution USP to Apotex Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.