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November 3, 2011

US drug approval rates higher than ever

Over the past 12 months, the US Food and Drug Administration (FDA) approved 35 new medicines, the second highest approval rate this decade.

By Daniel Garrun

Over the past 12 months, the US Food and Drug Administration (FDA) approved 35 new medicines, the second highest approval rate this decade.

Amongst the approved new drugs are two lifesaving medicines for hepatitis C, breakthroughs in personalised medication for melanoma and lung cancer and a drug for late-stage prostate cancer.

A new drug for Hodgkin’s lymphoma is also available, the first in 30 years, as well as the first new drug for lupus in 50 years.

A new report released today revealed that 24 of the 35 approvals occurred in the US before any other country.

FDA Commissioner of Food and Drugs Margaret Hamburg, MD, said that 35 major drug approvals in one year represented a very strong performance.

"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," Hamburg said.

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The FDA cites expedited approval processes and flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act as major factors behind the high approval rates.

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