FDA Reducing Generic Drug Application Backlog
Friday, October 23, 2015
The FDA is well ahead of schedule in reducing the backlog of generic drug applications, officials said last week.
Overall, the agency has 5,707 applications that were received prior to Oct. 1, 2014, 3810 of which are currently undergoing some form of review. Of the remainder, 1,293 were approved, 206 were deemed “refuse to receive” and 398 were withdrawn. Less than 10 percent of the total has seen no filing review or communication.
Included in the 5,707 are 2,866 ANDAs that were pending as of Oct. 1, 2012, when GDUFA took effect. The FDA has acted on 80 percent of those and must review and act on 90 percent of that number by Sept. 30, 2017, according to GDUFA requirements.