With only three months remaining in Fiscal Year 2018, the US Food and Drug Administration (FDA) is on target to approve a similar number of generic drugs as it did in Fiscal 2017. Fiscal 2018 marks the first year of the agency’s second generic drug user fee program in which FDA focused on boosting generic drug competition, new performance goals and program enhancements, reported RAPS.1
FY2018 Abbreviated New Drug Applications
As of now in FY 2018, FDA has approved 496 abbreviated new drug applications (ANDAs) and tentatively approved 114 ANDAs. These numbers are very similar to the agency’s Fiscal 2017 performance during this same period, which included full approval for 477 ANDAs and tentative approval for 119 applications.1
In all of FY 2017, FDA approved 763 ANDAs and tentatively approve 174 applications. However, 63% of those approvals took place in the second half of the year.2 October, November and December 2017 saw a much higher than normal rate of approvals.
January and February 2018 saw a decline in the number or approved ANDAs at 25 and 32 full approvals. The months of March through May saw increased numbers, back to normal levels compared to 2017. There was 57, 66 and 67 full approvals during those three months.3
In Fiscal 2018, with three remaining months, FDA has already issued more complete responses for ANDAs than it did in Fiscal 2017 year.1
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