RT Book, Section A1 Murri, Nelda A2 Brunton, Laurence L. A2 Hilal-Dandan, Randa A2 Knollmann, Björn C. SR Print(0) ID 1164575902 T1 Goodman & Gilman Year in Review New and Noteworthy FDA Approvals T2 Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 13e YR 2017 FD 2017 PB McGraw-Hill Education PP New York, NY SN 9781259584732 LK accesspharmacy.mhmedical.com/content.aspx?aid=1164575902 RD 2024/03/29 AB The FDA approved 42 drugs and biologics of note in 2012. Sixteen are first-in-class agents indicated for the management of a variety of conditions (see eTable 1). The rest are agents pharmacologically similar to others already marketed (see part 2 of this series). Several of the 2012 pharmacological "firsts" represent therapies that target a specific genetic anomaly (see eTable 1). Two approvals, anthrax antitoxin (see eTable 1) and the new levofloxacin indication for plague (see part 2 of this series) were approved under FDA's Animal Efficacy Rule, which is used in cases where it is not feasible or ethical to conduct randomized controlled trials in humans. One new agent, cobicistat, is the first drug approved specifically as a pharmacokinetic enhancer. Cobicistat is an alternative to ritonavir for "boosted" antiretroviral therapy for HIV injections. Two are new radiologic diagnostic agents: Choline C-11 to help detect prostate cancer recurrence and florbetapir F 18 [amyvid] to help measure the density of brain β-amyloid plaques in patients with cognitive decline. Allogeneic cultured keratinocytes and fibroblasts in bovine collagen (GINTUIT) was approved and represents the first cell-based dental product for wound healing following mucogingival manipulation. GINTUIT is a cell "scaffold" product for topical administration that secrets human growth factors, cytokines, and extracellular matrix proteins to catalyze tissue regeneration and repair.1 The zilver ptx, a drug-eluting stent for placement in the femoropopliteal artery represents another first to treat peripheral artery disease. The stent is coated with paclitaxel, a drug proven to reduce the rate of restenosis.2 Finally, four noteworthy diagnostic tests that facilitate optimization of targeted drug therapies were licensed in 2012: