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FDA on Pace for Record Generic Approvals in 2018

Posted 04 September 2018 | By Michael Mezher 

FDA on Pace for Record Generic Approvals in 2018

With two months of data outstanding, the US Food and Drug Administration (FDA) is on pace to approve a record number of abbreviated new drug applications (ANDAs) in FY2018.

According to FDA's latest generic drugs program activity report, the agency has approved 666 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.

FDA's performance in FY2018 is a promising start to its second Generic Drug User Fee Act (GDUFA II) program and draws a sharp contrast to the conversation around generic drug approvals during the early years of GDUFA I.

In the lead-up to GDUFA I, FDA had built up a backlog of thousands of ANDAs and prior approval supplements (PAS) that the agency struggled to work through before receiving additional funding through user fees.

FDA Commissioner Scott Gottlieb has also made the approval of generic drugs, especially first generics and generics to drugs with little competition, a priority as part of the agency's efforts to address growing prescription drug spending.

Despite those efforts, first-time generic drug approvals in 2018 are unlikely to surpass 2016 and 2017 levels, with only 49 first-time ANDAs approved into August 2018, compared to 80 in 2017 and 73 in 2016.

Additionally, the number of ANDA submissions in FY2018 has dropped slightly compared to the previous year but are still higher than the number of submissions the agency received in 2016.

FDA has also rejected a much higher number of ANDAs than in previous years, with nearly 2,400 complete responses so far in 2018 compared to 1,603 in 2017.



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