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FDA: 35 Innovative New Drugs Approved in Fiscal Year 2011
Date:11/3/2011

SILVER SPRING, Md., Nov. 3, 2011 /PRNewswire-USNewswire/ -- Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin's lymphoma in 30 years; and the first new drug for lupus in 50 years. 

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In a report released today, FY 2011 Innovative Drug Approvals, the FDA provided details of how it used expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals to 35 for the fiscal year (FY) ending Sept. 30, 2011.  The approvals come while drug safety standards have been maintained.

The report shows faster approval times in the United States when compared to the FDA's counterparts around the globe. Twenty-four of the 35 approvals occurred in the United States before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines.  

"Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients," said Margaret Hamburg, M.D., Commissioner of Food and Drugs. "We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century."

Among the new drugs approved in FY 2011, a number ar
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SOURCE U.S. Food and Drug Administration
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