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FDA approvals total 27 in 2013


FDA approved 27 new drugs last year, down from 39 new medications in 2012, which was a 15-year high, the Associated Press reported.

FDA approved 27 new drugs last year, down from 39 new medications in 2012, which was a 15-year high, the Associated Press reported.

In spite of the decline, FDA said that the number of innovative drugs approved in 2013 is in line with the historical trend. FDA has approved 28 new drugs annually over the past 5 years on average.

“While the number of FDA drug approvals has declined from 39 new drugs in 2012 to 27 in 2013, FDA continues to demonstrate its ability to focus on ensuring that cutting-edge and innovative drugs are made available to certain populations that might otherwise not receive these high-level drug treatments,” said Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala. “For some population these drugs approval can mean the difference between life and death.”

The number of drug approvals declined in 2013 mostly because there were fewer drugs submitted for review. FDA reportedly received at least 32 applications for innovative drugs 2013, down from 41 in 2012. In general, reviewing new drug applications takes FDA between 6 and 10 months.

“The growing awareness, prevalence, and research that has been focused on cancer in general,” has made the approval of innovative cancer drugs in 2013 significant, according to Dr Farinde.

Those approvals included the expanded indication of sorafenib (Nexavar, Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals) to treat late-stage (metastatic) differentiated thyroid cancer; pertuzumab (Perjeta, Genentech, a member of the Roche Group) as part of a complete treatment regimen for patients with early stage breast cancer before surgery; and ibrutinib (Imbruvica, Pharmacyclics and Janssen) to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer. 

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