In 2013, the FDA’s Center for Drug Evaluation and Research approved 25 small molecular drugs and 2 biologic drugs, compared to 33 and 6, respectively, in 2012. Nine orphan new medical entities (NMEs) were approved, as were 8 cancer drugs, of which 6 were orphan NMEs. In addition, companion diagnostics information was provided for 3 of the cancer drug approvals and will appear on the drugs’ labels. Multiple NMEs were also approved for metabolic and endocrinological therapies, antivirals and medical imaging. Forty-one percent of new approvals were for drugs from companies that had never received FDA approval before. Thirteen drugs that were approved are estimated to have potential sales topping one billion dollars. The two new biologics approved were monoclonal antibodies. By therapeutic area, oncology, metabolic and endocrinology, medical imaging and antiviral drugs accounted for the largest share of approvals, at 30%, 11%, 11% and 11% of all CDER 2013 drug approvals, respectively.

Source: Nature Reviews Drug Discovery