FDA report: 35 new drugs approved in past year

SILVER SPRING, Md. — The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

In a new report titled "FY 2011 Innovative Drug Approvals," the agency said many of the drugs were important advances for patents, including two new drugs for hepatitis C, one 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. Others included one drug for melanoma and another for lung cancer that were approved with diagnostic tests — approvals that the FDA said were breakthroughs in personalized medicine. Ten of the new drugs are for rare, "orphan" disease states, such as hereditary angioedema.

"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," FDA commissioner Margaret Hamburg said. "We are committed to working with the 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."

The FDA said the report shows faster approval times in the United States compared with similar agencies in other countries: Of the 35 new drugs, 24 received approval in the United States before any other country. Part of the reason for this, FDA Center for Drug Evaluation and Research director Janet Woodcock said, was the Prescription Drug User Fee Act, passed by Congress in 1992.

"Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere," Woodcock said. "As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy."

Click here to read the FDA's report.


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