RT Book, Section A1 Murri, Nelda A2 Brunton, Laurence L. A2 Hilal-Dandan, Randa A2 Knollmann, Björn C. SR Print(0) ID 1179320231 T1 The Goodman & Gilman Year in Review: 2013 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 accessmedicine.mhmedical.com/content.aspx?aid=1179320231 RD 2024/03/29 AB The FDA approved 40 new drugs and biologics of note in 2013. Twenty-two are pharmacologically similar to others already marketed and 10 are newly licensed biologics (see part 2 of this series). The remainder represent eight first-in-class agents indicated for the management of cancer, diabetes, hepatitis C infection, hypercholesterolemia, multiple sclerosis, and pulmonary hypertension (eTable 1). Three drugs, ibrutinib (IMBRUVICA) for lymphoma (eTable 1), obinutuzumab (GAZYVA) for chronic lymphocytic leukemia (see part 2 of this series), and sofosbuvir (SOVALDI) for hepatitis C infection (eTable 1), were the first drugs to be approved under FDA's "breakthrough therapy" designation.1 Established in 2012, FDA reserves breakthrough designations for drugs exhibiting superior efficacy against serious diseases.