4 September 2018 - With two months of data outstanding, the US FDA is on pace to approve a record number of abbreviated new drug applications in FY2018.

According to FDA's latest generic drugs program activity report, the agency has approved 666 abbreviated new drug applications (ANDAs) in the fiscal year through July and has tentatively approved another 162 ANDAs. With an average of 67 ANDA approvals and 16 tentative approvals each month this year, FDA will likely top its record-setting FY2017 performance.

In FY2017, FDA approved or tentatively approved 937 ANDAs, breaking its previous record of 835 in 2016.

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