US FDA approves 35 new drugs in fiscal 2012

The US Food and Drug Administration approved a total of 35 new drugs in its fiscal year ended September 2012, matching the number in the previous year, 31 of which were classified as New Molecular Entities (NMEs), beating the previous year total.

The new drugs approved by the agency included 10 cancer drugs, treatments for cystic fibrosis, rheumatoid arthritis and HIV, a meningitis vaccine and the first cord blood product, the agency said in a report released yesterday. Two weight loss drugs, the first such products in more than a decade, were also cleared for marketing during 2012, though one – Vivus’ Qsymia - was not classified as an NME because if comprised two active ingredients that had previously been approved.

Most of the drugs were approved for US patients before they were available in other countries, and the efficiency of the drug review process continued to grow, the FDA noted. The agency was the first to approve 75%, or 24 of 32 drugs cleared in other countries, according to the report. Of the 35 new drugs in the fiscal year, 77% were approved without the need for additional information that lengthens review time, noted a report by Bloomberg.