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# CDER Approved 22 Novel Drugs in 2016
- URL: https://www.fdaweb.com/cder-approved-22-novel-drugs-in-2016/
- Published: 2017-01-19T12:00:00.000Z
- Updated: 2026-09-14T22:01:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137766

CDER’s sixth annual Novel Drug Summary says the Center approved 22 novel drugs in calendar year 2016, either as new molecular entities (NMEs) under NDAs or as new therapeutic biologics under BLAs. “Novel drugs are often innovative products that serve previously unmet medical needs or otherwise significantly help to advance patient care and public health,” the report says. “NMEs have chemical structures that have never been approved before. However, in some cases an NME may have actions similar to earlier drugs and may not necessarily offer unique clinical advantages over existing therapies.”

Although the Center approved a lower-than-average number of novel drugs in 2016, the number of applications for such drugs that sponsors have submitted over time has remained relatively stable, the report says.

Listed are eight first-in-class drugs among the 22 that were approved: Jazz’ Defitelio, Sarepta’s Exondys 51, Intercept’s Ocaliva, Biogen Idec’s Spinraza, Shire’s Xiidra, Biogen and AbbVie’s Zinbryta, and Merck’s Zinplava.