FDA Approves 35 New Drugs in 2014

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FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.


Although the number of filings for new drugs dipped slightly in 2014, FDA reports that the number of new molecular entities and new therapeutic biologics approved in 2014 exceeded the number of approvals last year and the 10-year average of approvals.  

FDA’s Center for Drug Evaluation and Research (CDER) reported that as of Dec. 3, it has approved 35 novel new drugs in 2014 compared to 27 in 2013. The approvals include new molecular entities (NMEs), submitted to CDER in New Drug Applications, and new therapeutic biologics submitted to CDER in Biologics License Applications.

In a presentation at the FDA/CMS Summit on Dec. 11, John K. Jenkins, director of CDER’s Office of New Drugs, reported that the commercial investigational new drug pipeline of new drugs under development remained strong, driven by biologics. Through Dec. 3, CDER had received 35 NME applications in 2014, slightly above the 10-year average of NME filings of 34. The 35 NMEs approved thus far in 2014 exceeds the 10-year average of 26 approvals.

Of the 35 NMEs approved, seven were designated as breakthrough drugs; 15 were orphan drug designations, the highest since the passage of the Orphan Drug Act. Ten approved drugs were biologics; in 2013, only two biologics were approved.


In a blog entry, Margaret Hamburg, Commissioner of FDA noted specific approvals for cancer, hepatitis C, and antibacterial drugs.

Hamburg also noted that 34 of the 35 drugs approved thus far in 2014 received approval before or on their Prescription Drug User Fee Act review goal date; 23 of the 35 drugs were available to patients in the United States before they were available to patients in Europe.

Click here for the presentation link.

Source: FDA