Thursday, September 19, 2019

Thursday, September 19, 2019

FDA approvals of new drugs, biological products dip slightly in FY2019


New drug and biological product approvals were down slightly in the first three quarters of the current fiscal year, compared to the same period in the previous year, according to data released by the U.S. Food and Drug Administration.

In the current fiscal year, as of June 30, approvals of new drug applications and biologics license applications numbered 104, down from the 112 approved after three quarters in the 2018 fiscal year, the FDA reported.

The total number of applications filed for these products was also down slightly during the first three quarters of FY2019, compared to the same period during the previous fiscal year, according to the latest agency numbers. Publication of the data was authorized by the FDA Reauthorization Act of 2017.

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NDA and BLA Approvals in FY 2019

Application Type1st Quarter2nd Quarter3rd Quarter4th QuarterCumulative
New Drug Applications372524

86
Biologics License Applications747

18
Total442931

104
Source: Food and Drug Administration

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U.S. Food and Drug Administration (FDA)

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