Posted by Michael Wonder on 13 Oct 2016
FY 2016 generic approvals by FDA: a new record under GDUFA
12 October 2016 - The US FDA published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this month, revealing 651 approvals (though it’s 835 if tentative approvals are included), which was 159 more than the number of approvals for FY 2015 and 242 more than the agency approved in FY 2014.
But that high approval figure for last year also comes as the agency sent more complete response letters (CRLs) than any other year. The 1,725 CRLs issued in 2016 was 545 more than what FDA issued in 2015.
The uptick in ANDA approvals and rejections for the latest fiscal year is thanks to almost 1,000 new employees that FDA was able to hire because of the Generic Drug User Fee Amendments (GDUFA), which is meant to help reduce the ANDA backlog.
