FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

CDER Celebrates Novel Approvals and Highlights Other Firsts in 2017

Jan. 16, 2018

CDER achieved numerous firsts in its past year of drug approvals, covering treatments for several rare diseases, cancer therapies and antibiotics.

According to CDER Director Janet Woodcock, 36 of the 46 novel drugs approved in 2017 were approved in the U.S. before any other country — and 100 percent were approved within their targeted PDUFA date.

The 46 more than doubles the 22 novel drugs approved by the agency the year before, and beats the average of 31 approvals from 2008 to 2016.

For the first time in 20 years, the agency approved a new drug to treat sickle cell disease, Emmaus Medical’s Endari (L-glutamine).

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