Drugs

FDA Extends Neffy NDA Review

FDA has extended by three months an ARS Pharmaceuticals NDA for neffy (intranasal epinephrine) for treating allergic reactions (Type 1), including anaphylaxis, for adults and children. The revised user fee review action target date is 9/19.

Shortly after a favorable 5/11 vote (see story) by FDA’s Pulmonary-Allergy Drug Advisory Committee (PADAC) meeting, the agency told the company it needed more review time for labeling and post-marketing commitment discussions, according to ARS. Additionally, the company recently submitted proposals for post-marketing commitments based on input from the advisory committee meeting that need to be reviewed.

Meanwhile, ARS was met with a citizen petition challenge last week (see story) from Viatris that urged the agency to require additional pharmacokinetic and pharmacodynamic studies to support the neffy NDA. “Viatris believes the totality of currently available evidence does not yet answer several critical questions regarding how [neffy] will perform in a real-world anaphylaxis event,” the petition said.

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