Drugs

Vanda Can Seek Tradipitant Hearing: FDA Notice

FDA has published a Federal Register notice indicating its intention to deny the Vanda Pharmaceuticals NDA for tradipitant capsules, 85 mg, in its present form and offering the company the opportunity to request a hearing with the commissioner. The notice says the NDA seeks an indication for “the treatment of [symptoms of] or [nausea in] gastroparesis.”

The CDER Office of Immunology and Inflammation issued a 9/18/2024 complete response letter to Vanda saying that the NDA could not be approved in its present form because the application did not provide substantial evidence of effectiveness for the drug and did not demonstrate that it is safe for the proposed conditions of use. The letter described the specific deficiencies that led to CDER’s determination and, where possible, recommended ways that Vanda might remedy the deficiencies.

The notice says that on 11/25/2024, Vanda indicated it wanted to receive approval of its NDA or a notice of an opportunity for a hearing. It says that if Vanda chooses to seek a hearing, it must submit the studies, data, information, and analyses relied upon to justify a hearing. “The commissioner will grant a hearing if there exists a genuine and substantial issue of fact or if the commissioner concludes that a hearing would otherwise be in the public interest,” FDA says.

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