USA – FDA Approves First Generic Drug to Receive CGT Designation

The US Food and Drug Administration 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…