Drugs

FDA OKs Acacia Nausea Drug

FDA has approved an Acacia Pharma Group NDA for Barhemsys (amisulpride injection) for preventing and treating postoperative nausea and vomiting (PONV) in adult patients. Approval of the selective dopamine D₂ and D₃ antagonist was based on data from four positive Phase 3 studies involving more than 3,300 surgical patients and healthy volunteers, the company says. The drug is intended for patients who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis and the prevention of PONV, either alone or in combination with an antiemetic of a different class.

The most common side effects observed during the studies were: infusion site pain (6% vs 4% with placebo), chills (4% vs 3%), hypokalemia (4% vs 2%), procedural hypotension (3% vs 2%), and abdominal distension (2% vs 1%).

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome