Bloomberg News

FDA Approves 35 Drugs in Fiscal 2012 to Match 2011 Tally

December 05, 2012

The U.S. cleared 35 drugs for sale in fiscal 2012, matching the total for those that made it to market in the previous year, regulators said.

The Food and Drug Administration approvals of novel medicines included 10 cancer medicines, as well as treatments for cystic fibrosis and HIV, a meningitis vaccine and the first cord blood product, the agency said today in a report.

“Most of the drugs were approved for U.S. patients before they were available in other countries, and the efficiency of the drug review process continued to grow,” the FDA said in the report.

The agency was the first to approve 75 percent, or 24 of 32 drugs cleared in other countries, according to the report. Of the 35 new drugs in the fiscal year, 77 percent were approved without the need for additional information that lengthens review time.

For the calendar year, U.S. regulators have approved 31 novel new drugs, beating the FDA’s seven-year high of 30 last year, according to the agency’s website.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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