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FDA approved 45 novel new drugs in 2015, led by therapies for orphan diseases and and expedited approvals.
With a flurry of activity in the last two months of the year, FDA approved 45 novel new drugs in 2015 (1), the highest number of approvals since 1996 and second-highest ever (2). “But far more important than quantity is quality-and the valuable new roles many of these drugs can serve in advancing medical care and the health of patients,” said John Jenkins, director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (CDER) (3).
The agency approved 87% of the applications on the first cycle of review and met or exceeded the goal dates under the Prescription Drug User Fee Act for all but two of novel new drugs approved. FDA’s expedited pathways for drug approval again proved successful in 2015:
Novel new drugs approved in 2016
In addition to the 30 novel new therapies reported previously (4), the following new drugs were approved by FDA between Nov. 1–Dec. 31, 2015:
1. FDA, Novel New Drugs Summary 2015, online accessed Jan. 5, 2105.
2. FDA, Summary of NDA Approvals & Receipts, 1938 to the present, online accessed Jan. 5, 2015.
3. J. Jenkins, 2015: Another Strong Year for Patients in Need of New Drug Therapies, online, accessed Jan. 5, 2015.
4. C. Challener, Pharmaceutical Technology 39 (12) 2015.