FDA approves 35 novel new drugs in 2014

SILVER SPRING, Md. — To date, the Food and Drug Administration's Center for Drug Evaluation and Research has approved 35 novel new drugs in 2014, compared to 27 in 2013. These numbers include both new molecular entities submitted to CDER in New Drug Applications and new therapeutic biologics submitted to CDER in Biologics License Applications.

 

"But the numbers don’t tell the full story," Margaret Hamburg, FDA commissioner, wrote in a recent FDA blog post. "What really matters is that many of these new products offer significant clinical value to the care of thousands of patients with serious and life-threatening diseases. ... So far this year, we’ve reached a milestone with a record 15 approvals for rare diseases. The previous high was 13 drugs in 2012," she noted. "And here’s another point of interest — to date, 15 of the approvals have been first in their class drugs, another indicator of their potentially strong clinical impact."

 

According to Hamburg, 34 of the 35 new drug approvals were approved on or before their Prescription Drug User Fee Act review goal date, and 23 of the drugs were available to patients in the United States prior to their approval in Europe.