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The FDA approved 33 drugs and biologics of note in 2011. Most are pharmacologically similar to others already marketed (see eTable 2). Among the remainder are 18 "first-in-class" agents for acute coronary syndrome, angioedema, chronic obstructive pulmonary disease, congenital factor XIII deficiency, depression, head lice, hepatitis C infection, lupus, lymphoma, melanoma, myelofibrosis, prostate cancer, seizures, diagnosis of Parkinsonian syndromes, and vaccination of military personnel against adenovirus (see part 1 of this series). Fourteen of the new drug approvals in 2011 were granted orphan drug status for rare diseases (see eTable 2, eTable 3, and part 1 of this series). Two of the new drugs (crizotinib for non-small cell lung cancer and vemurafenib for melanoma) were approved in conjunction with diagnostic genetic tests and represent a breakthrough in the field of personalized medicine.1 In addition, one new approval, HEMACORD is the first cord blood therapy approved in the US.2

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eTable 2.New Drugs Licensed in 2011 with Pharmacological Mechanisms Similar to Previously Approved Drugs

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