TY - CHAP M1 - Book, Section TI - Goodman & Gilman Year in Review New and Noteworthy FDA Approvals A1 - Murri, Nelda A2 - Brunton, Laurence L. A2 - Hilal-Dandan, Randa A2 - Knollmann, Björn C. PY - 2017 T2 - Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 13e 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. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/03/28 UR - hemonc.mhmedical.com/content.aspx?aid=1164575932 ER -