Drugs

Vanda Sues FDA Over Rejected Hetlioz sNDA

Vanda Pharmaceuticals has filed a lawsuit in the DC District Court against FDA seeking an order to compel it to publish in the Federal Register a notice of opportunity for a hearing related to a complete response letter (CRL) on a supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder. The complete response was issued in 2019 and cited “measures” contained in the sNDA demonstrating improved sleep have “unclear clinical significance,” the company said at the time (see story).

After the CRL was issued, Vanda unsuccessfully attempted to resolve the matter under FDA’s dispute resolution. It further complains that the submission has since been sitting in regulatory purgatory, until the company 7/1 formally requested an opportunity for a hearing on the approvability of the sNDA.

On 8/22, “FDA privately delivered to Vanda what the agency characterized as a notice of opportunity for hearing,” the company’s complaint says. “That notice was not, and still has not been, published in the Federal Register consistent with 21 CFR § 314.200(a). Worse, FDA has refused to provide any date certain for publication in the Federal Register, taking the position in correspondence with Vanda that there is no deadline to publish the notice and thereby complete the statutorily required ‘notice’ and begin the hearing process, consistent with FDA’s regulation.”

Worried that FDA could delay indefinitely its request for a hearing, Vanda has asked the court to compel the agency to either approve the sNDA or publishing a notice of an opportunity for hearing in the Federal Register.

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