Drugs

Court Orders FDA Hetlioz Action

The DC federal court has ordered FDA to either resolve a Vanda Pharmaceuticals sNDA for its Hetlioz (tasimelteon) to treat jet lag disorder or start a hearing on the sNDA on or before 3/5. The court’s ruling came as it granted Vanda summary judgment in its 9/2022 suit claiming that the agency did not meet its legal obligations to either approve the sNDA or provide an opportunity for a hearing.

In a statement, Vanda says it submitted the sNDA in 10/2018. The statement quotes the court’s decision that “the statute requires that a hearing shall commence within 300 days after an application is filed. Vanda’s application has been pending for almost 2,000 days and it has been over 500 days since Vanda made its most recent request for a hearing.”

The company says the decision “highlights the serious flaws in FDA regulations governing drug approval processes and it reinforces FDA’s clear statutory obligations to render timely final decisions on drug applications. It appears from this case, and from FDA’s standard policies, that FDA decision-makers have implemented a policy of following FDA’s own timelines, resulting in unlawful actions that are systemic. FDA’s extraordinary delays impede medical innovation to the detriment of the many patients with unmet needs who lack effective therapeutics.”

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