Approvals for 505(b)(2) Drugs Slower Than for NMEs, Report Says

The 505(b)(2) approval pathway, designed to expedite reviews, actually takes about five months longer than the standard NDA process, says a new report from the Tufts Center for the Study of Drug Development.

Between 2009 and 2015, the average approval time for 505(b)(2) applications — which rely on previously generated data from drug sponsors or the FDA — was 18.4 months, compared to 13.8 months for NME applications, the report said.

Under PDUFA V, the FDA committed to review 505(b)(2) applications in 10 months, but the average time for a first-cycle approval is closer to the 12-month review goal for NMEs. Only 49 percent were granted approval on the first cycle, compared to 78 percent of NMEs, the report said.