The US Food and Drug Administration (FDA) reported having approved
35 new medicines over the past 12 months, the second-highest number of
approvals in the past decade and topped only by the agency’s 37
approvals in 2009. The report comes as Congress is considering
reauthorization of the Prescription Drug User Fee Act, due next
year. “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 FDA
Commissioner Margaret Hamburg in a statement. FDA noted some of the
approved drugs it deemed important medical advances, 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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