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# FDA Approved 45 New Drugs/Biologics in 2015
- URL: https://www.fdaweb.com/fda-approved-45-new-drugs-biologics-in-2015/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:24:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134294

New molecular entity (NME) approvals for drugs and biologics soared to 45 last year, four (9%) more than 2014 and the most approved in almost two decades. To see a full listing of products approved, [click here](http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm?ref=fdaweb.com).

In December, CDER Office of New Drugs director **John Jenkins** acknowledged ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5134211&searchWords=jenkins&cate=S&stid=%241%24aK..bj0.%24OVLfdgc1Q%2F%2FfHzE9O%2Fg2d1&ref=fdaweb.com)) the record approval pace, but he cautioned it could be short lived because NME submissions are flat, with only 36 such submissions received through 12/9.

Jenkins said CDER was seeing tremendous progress for first cycle approvals for standard/priority applications, with these hovering around 95% in 2015\. He said the Center has not changed approval standards, rather industry has made changes that have improved the first cycle approval rate. He cited additional factors that may be contributing to the improved approval rate, which include: 

- FDA guidance/meetings during IND to clarify expectations for development programs – improves quality of NDAs/BLAs
- Complete applications at time of filing and more time for interactions with sponsor to address deficiencies
- Targeted therapies – greater benefit/less risk in selected patients
- More orphan drugs – alters benefit/risk balance
- Breakthrough designation – “all-hands on deck” for sponsor and FDA
- Focus of sponsors away from “me too” drugs and diseases with available treatment options with less favorable benefit/risk balance (He noted that this is not necessarily a good outcome from a public health perspective because often a ”me too” drug becomes the “me better” drug.)

In reviewing CDER’s review performance, Jenkins noted that more than half (56%) of the novel drugs approved to date went through Priority Review and 22% of these had received a breakthrough therapy designation. Other notable review data: nearly half (46%) of the NMEs approved to date were for rare diseases; over one-third (37%) of the NMEs approved were first in their class; and two-thirds (66%) of NMEs approved to were first approved in the U.S.