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In 2016, FDA Drug Approvals Hit a Six-Year Low

December 30, 2021

The U.S. Food and Drug Administration (FDA) approved 22 medications in 2016, which was the lowest number of FDA approvals in a single year since 2010. In comparison, the FDA approved 45 news drugs in 2015, with 2014 and 2015 approvals representing a 19-year high.

FDA officials attributed the decrease in approvals to fewer new drug filings last year, and noted that the FDA rejected or delayed more applications compared with previous years. In addition, many drugs that were scheduled for approval in early 2016 received approval before the end of 2015 (such as the myeloma drugs elotuzumab, ixazomib, and daratumumab).

The slowdown suggests the pharmaceutical industry may be returning to more normal productivity levels following a spike in drug approvals in 2014 and 2015.

This trend was also seen in Europe, with the European Medicines Agency recommending 81 new prescription products last year, down from 93 in 2015.

Source: Reuters, January 2, 2017.

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