FDA approved 35 new drugs during the latest fiscal year

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Medicare might have made duplicate payments for medications used by hospice beneficiaries, OIG repor
Medicare might have made duplicate payments for medications used by hospice beneficiaries, OIG repor
The Food and Drug Administration green-lighted a bumper crop of new medicines in fiscal year 2011. It happened due to expedited approval authorities, flexibility in clinical trial requirements and PDUFA measures aimed at boosting approvals of innovative compounds, the agency said.

FDA approved 35 new medicines over the course of the fiscal year, delivering the agency's second-biggest lot of innovative drugs in the past decade (bested only by 2009's total of 37).

Approvals included new drugs in personalized medicine for melanoma and lung cancer, 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.

Seven of the drugs represent major advances in cancer treatment, the agency said. Almost half were found to be significant therapeutic advances over existing therapies for heart attack, stroke or kidney transplant rejection.

FDA noted in its report “FY 2011 Innovative Drug Approvals” that 24 of the new drugs were first approved in the United States and that it is delivering on increased PDUFA fees.

“Thirty-five major drug approvals in one year represents a very strong performance, both by industry and the FDA,” and we continue to use every resource possible to get new treatments to patients,” said FDA Commissioner Margaret Hamburg, M.D.

David Wheadon, PhRMA, the FDA's SVP of scientific and regulatory affairs, hailed the news, saying that the tally “demonstrates the shared commitment of biopharmaceutical research companies and the agency to medical progress and patient care.”

“By approving these new medicines, FDA is helping to provide patients with access to new medicines that offer hope in meeting unmet medical needs,” Wheadon added.