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# CDER Approvals Double to 46 Innovative Products
- URL: https://www.fdaweb.com/cder-approvals-double-to-46-innovative-products/
- Published: 2018-01-02T12:00:00.000Z
- Updated: 2026-09-14T23:09:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140373

CDER innovative drug approvals sharply rebounded in 2017 — more than doubling the 22 products approved in 2016, which was a significant down year for approvals. In all, the Center approved 46 innovative NDA/BLAs last year. In contrast, there were just 22 approved in 2016 and 45 in 2015, according to approval [reports](https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm?ref=fdaweb.com).

Preliminary data released by CDER officials [last month](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM587690.pdf?ref=fdaweb.com) showed that the U.S. continues to lead the world in “first approvals” for innovative products (new molecular entities). The data showed that 2017 had a record number of orphan indications approved across all NDAs and BLAs, and new applications submitted increased across the board compared to five-year averages — 48 new molecular entities (NME) and original BLAs (14% increase), 106 non-NME NDAs (28% increase), and 231 efficacy supplements (43% increase).

2017 also saw continued efficiencies in first-cycle reviews, according to the officials. All of the NMEs/BLAs approved through early December met their user fee goal dates, and 88% of the drugs approved were approved in the first review cycle. And drug sponsors continue to favor FDA expedited development programs as follows:

- More than two–thirds (70%) of the drugs in 2017 were approved under priority review
- About four out of 10 (43%) of the drugs received a breakthrough therapy designation
- Almost half (45%) of the drugs approved received a fast track designation

As for CDER goals in 2018, the officials said recruitment and hiring continue to be a priority. A year ago, there were 1,108 full-time equivalents working at CDER. They projected that by 12/31/2017 there would be 1,198 on board — a net 90 (8%) more employees over the past year. The officials expect to be implementing the new user fee agreements this year and activities related to the 21st Century Cures Act.