The number of generic drugs approved by the FDA fell sharply in fiscal 2020, ending a record year of growth
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After setting records for the number of generic new drug applications (ANDAs) approved for four consecutive years, the U.S. Food and Drug Administration (FDA) has broken records, with 22 percent fewer generic drug approvals in fiscal 2020 compared to fiscal 2019.

In fiscal year 2020, the FDA approved a total of 909 ANDAs, 737 formal approvals and 172 provisional approvals, compared with a record 1,171 ANDAs in fiscal year 2019. Complete responses also fell to 2,010 from 2,310 in FY19. (Related: Another record year for generic drug approvals, but questions about competition remain, Oct. 16, 2019; FDA again sets a record number of generic drug approvals, October 11, 2018).

* Excluding data from September 2020 (the U.S. government fiscal year runs from October 1 to September 30)

Before approval decreased, the FDA has been increased attention to the backlog of generic application review, it is a former FDA commissioner Scott Gottlieb (Scott Gottlieb) advocated by the drug competition is part of a plan of action, in the second generic user fee amendment (GDUFA II) emphasized in practice the application for the first three years of the old act, leading to a record high after approval.

It is unclear how much impact COVID-19 has had on FDA approval of generic drugs due to limitations in conducting facility inspections and diverting resources to respond to COVID-19. The F.D.A. said it was working to meet its royalty commitments, but officials acknowledged that certain dates had been missed because it was unable to conduct on-site preapproval inspections. (Related: FDA explains COVID-19 pair application, formal meeting, May 27, 2020; Top CDER officials discuss budget priorities, staffing, and COVID-19, October 16, 2020)

Despite the decline in FY19 approvals, the number of ANDA approvals was still higher than FY16 and only slightly lower than FY17 and FY18 approvals.

The decline in the number of ANDA submissions received by the FDA has also contributed to the decline in the number of approvals for several years, dropping from a peak of 1,306 applications in fiscal year 2017 to last year. And the number of denial of acceptance (RTR) applications issued by the FDA has steadily declined since fiscal 2016.


Key words: Generic drugs New drug application, US Food and Drug Administration (FDA), Generic drugs


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