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In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.
FDA’s Office of Generic Drugs (OGD) released their 2016 Annual Report on Feb. 24, 2017. The report details the office’s accomplishments for the year, including the most-ever approved (630) or tentatively approved (183) abbreviated new drug applications (ANDAs) in the history of the generic drug program.
The report highlights some of the office’s top achievements in 2016, including meeting Generic Drug User Fee Act (GDUFA) performance goals, which were established by he Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). These goals included the agency taking a first action on 90% of the 2866 ANDAs and 1873 post-approval studies (PASs) in process with FDA or industry prior to GDUFA enactment on October 1, 2012. In Spring 2016, the agency met this commitment more than a year ahead of schedule. As of December 31, 2016, FDA had completed first actions on 95% of ANDAs and 93% of PASs.
Additional highlights of the report include the following:
“It is exciting to see the number of approvals and tentative approvals continuing to rise, but our main focus is always to ensure the safety, effectiveness, and quality of FDA-approved drugs,” OGD’s director, Kathleen Uhl, MD, stated in the report. “We have also begun leveraging international generic drug activities to better understand drivers of the global drug market, which is critical to ensuring consistent quality in generic drugs sold in the United States.”