Thursday, September 19, 2019

Thursday, September 19, 2019

Applications for new drugs, biological products dip slightly in FY2019


New drug and biological product application filings 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, the filing of new drug applications and biologics license applications numbered 123, down from the 128 approved after three quarters in the 2018 fiscal year, the FDA reported.

The total number of new drug and biological product approvals 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 Filings in FY 2019

Application Type1st Quarter2nd Quarter3rd Quarter4th QuarterCumulative
New Drug Applications532530

108
Biologics License Applications348

15
Total562938

123
Source: Food and Drug Administration

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U.S. Food and Drug Administration (FDA)

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