FDA approves first generic drug under new pathway

Source: Xinhua| 2018-08-09 01:26:02|Editor: Mu Xuequan
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WASHINGTON, Aug. 8 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Wednesday approved multiple strengths of potassium chloride oral solution as the first generic drug to receive a Competitive Generic Therapy (CGT) designation.

CGT, a new approval pathway, was created to expedite the development and review of a generic drug for products that lack competition, according to FDA.

A drug can be designated as a CGT if there is inadequate generic competition for that drug, according to current FDA rules.

Potassium chloride is an oral treatment that is indicated for the treatment and prevention of 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.

Proper potassium levels are necessary for cells within the body to function properly. Low potassium levels can lead to abnormal heart rhythms.

"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.

Applicants for drugs that receive a CGT designation may receive review enhancements and are 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 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 final approval or it will forfeit its exclusivity.