The Latest on Backlog of ANDA Reviews

According to Kaiser Health News “As of July 1, the FDA had 4,036 generic drug applications awaiting approval, and the median time it takes for the FDA to approve a generic is now 47 months, according to the Generic Pharmaceutical Association, or GPhA. The FDA has approved more generics the past few years, but a flood of new applications has steadily added to the demand.” When asked about the lack of EpiPen competition, an FDA spokesperson “stressed that the FDA pushes pending applications for drugs with no current generics to the front of the line and approved a record number of generics in 2015.”  Click here for the full story on the ANDA review backlog. Feel free to contact us for help with your PK studies, ANDA or 505(b)(2) submissions.