New FDA Specialty Approvals

April 1

✦ March 9: The FDA approved Acacia Pharma Group plc’s Barhemsys (amisulpride) for the prevention of postoperative nausea and vomiting in adults either alone or with an antiemetic of a different class and treatment of PONV in adults who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis. Dosing for prevention of PONV is 5 mg via an intravenous injection over one to two minutes at the time of induction of anesthesia and 10 mg in the event of nausea and/or vomiting after a surgical procedure. The company says it expects the product to be available in the second half of this year. Visit https://barhemsys.com.

✦ March 9: The FDA expanded the label of Ofev (nintedanib) to include the treatment of people with chronic fibrosing interstitial lung diseases with a progressive phenotype. The agency initially approved the Boehringer Ingelheim Pharmaceuticals, Inc. capsule in October 2014 (RSP 11/14, p. 4); this is its third approval, and it had priority review and breakthrough therapy designations. The recommended dose is 150 mg twice daily approximately 12 hours apart. Website Drugs.com lists the price of 60 150 mg capsules as $10,955.35. Visit www.ofev.com.

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Radar on Specialty Pharmacy

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.