eChapter 71 (Part 1): The Goodman & Gilman Year in Review: 2011 New and Noteworthy FDA Approvals

PART 1 FIRST-IN-CLASS AGENTS

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 Table 71-1). Fourteen of the new drug approvals in 2011 were granted orphan drug status for rare diseases (see Table 71-1 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