Generic Drug Approvals See Slight Uptick in February
The FDA’s Office of Generic Drugs approved 61 applications in February, marking a slight uptick in generic drug approvals.
Several of the approvals were for applications in the FDA’s ANDA backlog, which contained 4,700 applications in October 2012. The agency said it has cleared the backlog of unreviewed applications.
In July 2016, the FDA reported taking at least first review action on 90 percent of the ANDAs and prior approval supplements in the backlog, but said many applications would require more than a single round — as the rate of first-cycle approvals for ANDAs remains at about 9 percent.