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Pharmaceuticals / Submissions and Approvals

FDA Novel Drug Approvals Spiked Last Year

Jan. 8, 2018
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The FDA approved 46 novel drugs in 2017, hitting a two-decade high after approvals plunged in the previous year — a record 53 novel drugs were approved in 1996.

The FDA granted approval to just 22 novel drugs in 2016, down from 45 in 2015.

Many of the 2017 approvals covered treatments for rare conditions, including numerous sub-types of cancer.

The agency issued six priority review vouchers for the year, including for BioMarin Pharmaceutical’s Brineura for treatment of Batten disease, and Chemo Research’s benznidazole for treatment of pediatric Chagas disease — the first Chagas drug approved for use in the United States.

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