New FDA Specialty Approvals

✦ 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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