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PART 1 FIRST-IN-CLASS AGENTS

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The FDA approved 33 drugs and biologics of note in 2011. Most are pharmacologically similar to others already marketed (see part 2 of this series). 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 eTable 1). Fourteen of the new drug approvals in 2011 were granted orphan drug status for rare diseases (see eTable 1 and part 2 of this series). Two of the new drugs (crizotinib for non-small cell lung cancer (see part 2 of this series) 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 1.New Pharmacological Drug Classes Introduced in 2011

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