2014 FDA Drug Approvals Outpace 2013

December 15, 2014

In 2014, the Food and Drug Administration (FDA) approved 35 novel drugs, outnumbering the 27 approved in 2013.

Thirty-four of the 35 drugs approved so far this year were approved before or on their Prescription Drug User Fee Act (PDUFA) review goal date, according to a Dec. 11 blog post from the FDA. Fifteen of the approvals to date were of drugs that were first in their class, and a record-breaking 15 approvals were of drugs for rare diseases, topping the previous record of 13 in 2012.

The FDA credits, in part, this year’s large number of novel drug approvals to the FDA’s expedited development and review programs, such as fast track, priority review, accelerated approval and its new breakthrough therapy designation.

Highlighted drugs from this year’s approval class include Blincyto™, which treats Philadelphia chromosome-negative precursor B-Cell acute lymphoblastic leukemia; Harvoni®, the first combination pill approved to treat chronic hepatitis C virus genotype 1 infection and the first approved regimen that doesn’t require administration with interferon or ribavirin; and three new antibacterial drugs to treat skin infections: Dalvance™, Sivextro™ and Orbactiv™.