WASHINGTON -- The FDA debuted a new process for reviewing generic drug applications in approving oral potassium chloride solutions made by Apotex.
Several strengths of the KCl solutions, used to treat hypokalemia, were approved Wednesday and are the first to be reviewed under a so-called Competitive Generic Therapy (CGT) designation authorized by Congress last year.
"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, MD, in a . "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."
Under this new authority, the FDA can use the accelerated process for any drug that has either one or no versions listed in the agency's of approved generic products. Companies can apply for the CGT designation that provides rapid review and also a 6-month period of market exclusivity in some cases. Apotex's KCl solutions qualified for such a period, the FDA said. But with that marketing exclusivity comes a requirement that the sponsor actually market the product within 75 days.