US Pharm. 2015;40(2):5.
Silver Spring, MD—The FDA’s Center for Drug Evaluation and Research (CDER) approved 41 novel new drugs in 2014, 14 more than in 2013 and the highest number in almost 20 years. These new molecular entities or therapeutic biologicals include eight therapies for various types of cancer, four agents for type 2 diabetes, four antibiotics to treat serious infections, and two products to treat patients with hepatitis C. Seventeen of these new drugs were approved to treat rare diseases that affect fewer than 200,000 Americans, the highest yearly total ever. The CDER also gave “First-in-Class” designation to 17 drugs, an indicator of the medication’s degree of innovation.
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