FDA OKs First Generic Under Pathway to Support Competition for Sole-Source Drugs

The US Food and Drug Administration (FDA) has approved the first generic drugs to receive a competitive generic therapy (CGT) designation. This new approval pathway by the FDA was created to expedite the development and review of a generic drug for products that lack competition.

“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 FDA Commissioner Scott Gottlieb in an August 8, 2018 agency statement. “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.”

In making its first approval under this pathway, the FDA approved several strengths of potassium chloride oral solution from Apotex, a Toronto-headquartered generic pharmaceutical company. Potassium chloride is an oral treatment that is indicated for treating and preventing 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.

Under new authorities provided to the agency in the FDA Reauthorization Act of 2017, a drug can be designated as a CGT 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, which publishes all FDA-approved drug products with therapeutic equivalence. 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 Apotex potassium chloride oral solution products approved (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.

Source: FDA


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