FDA approves first competitive generic therapy drug
The US Food and Drug Administration ( FDA) yesterday approved the first generic drug to receive a competitive generic therapy (CGT) designation.
The status was awarded to several strengths of potassium chloride oral solution which are used in the treatment and prevention of hypokalemia in patients that are on diuretics.
CGT designation was designed to speed up the development and review of a generic drug for products that lack competition.
The CGT approval of potassium oral solution was awarded to pharmaceutical company Apotex.
Scott Gottlieb, commissioner of the FDA, said that the programme is part of the administration’s broader efforts to encourage generic competition and 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,” said Gottlieb.
The potassium oral solution treatment was approved in its first cycle of review.
“This approval demonstrates that the competitive generic therapy pathway is efficient and open for business,” added Gottlieb.
The new rules were introduced as part of the FDA’s Reauthorization Act of 2017. The act defines a drug as having inadequate generic competition when there is only one approved drug in the active section of the Orange Book.
Applicants for drugs that receive CGT designation are also eligible for a 180-day period of marketing exclusivity if they are the first approved applicant for that CGT.
In addition, applicants that have products that receive the status may receive review enhancements and expedited review of their Abbreviated New Drug Applications.
“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,” added Gottlieb.
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