Drugs

Vanda Sues FDA to Allow Off-Label Promotion

Vanda Pharmaceuticals has filed a lawsuit against FDA that seeks a declaratory judgment giving the company protection under the First Amendment to promote Hetlioz (tasimelteon) for the off-label use of treating jet lag. The drug is currently approved for treating non-24-hour sleep-wake disorder, and Vanda had sought a new indication for treating jet lag disorder in 2019, but the agency declined approval and recommended it conduct at least one additional adequate and well-controlled study. The company subsequently submitted two formal dispute resolution requests that were denied by FDA.

Vanda’s complaint includes proposed promotional materials and reprints of three peer-reviewed studies that have evaluated Hetlioz as a treatment for jet lag. The company asks the court to declare that these communications are truthful and non-misleading. Additionally, it seeks a court action to permanently enjoin FDA from taking any adverse action against Vanda or its employees or directors related to these communications.

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