FDA, Regulatory

FDA approves first generic drug to receive CGT designation

The FDA on Wednesday approved several versions of Apotex’s potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation.

Thanks to the FDA Reauthorization Act of 2017 (FDARA), the CGT designation allows generic drugs to come to market faster than they otherwise would have, but only in cases where there is one approved competitor generic drug in the active section of the Orange Book.

Those receiving a CGT designation may receive review enhancements and expedited review of their abbreviated new drug applications (ANDAs). 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 other conditions.

And in a unique twist, 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.

Though the CGT is only for generics with one competitor, in an update to the agency’s Manual of Policies and Procedures (MAPP) in June 2017 on the prioritization of the review of ANDAs, FDA says: “Generic products for which there are fewer than three ANDAs approved for the reference listed drug (RLD) and for which there are no blocking patents or exclusivities on the RLD may receive expedited review.”

The potassium chloride oral solution products approved Wednesday (potassium chloride oral solution USP, 10% (20 mEq/15 mL) and 20% (40 mEq/15 mL)) are eligible for 180 days of CGT exclusivity and were approved in the first cycle of review, FDA said.

FDA Commissioner Scott Gottlieb said in a statement: “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.”

FDA in June 2017 also released two lists of generic drugs, each of which contain more than 100 active ingredients, including one “for which FDA could immediately accept an ANDA without prior discussion,” and the second for drugs “involving potential legal, regulatory, or scientific issues which should be addressed with the Agency prior to submission of an ANDA.”


First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information. 


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