Drugs

Milestone Pharma Files NDA Resubmission for Cardamyst

Milestone Pharmaceuticals has submitted its response to a March-issued FDA complete response letter on the company’s NDA for Cardamyst (etripamil) nasal spray and its use to convert acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. PSVT is described as a sudden, rapid, and irregular heartbeat (arrhythmia) that originates in the upper chambers of the heart (atria).

The agency’s letter requested additional information on nitrosamine impurities based on new draft guidance issued after the NDA submission, adding that a new FDA inspection of the facility that performs release testing for etripamil will be needed to ensure compliance with GMPs because of an ownership change during the NDA review.

Milestone says its response follows a Type A meeting recently held with FDA. “The acceptance of the response and corresponding Prescription Drug User Fee Act (PDUFA) date will be determined within the next thirty days per FDA policy,” it says. “The review time is expected to be within two or six months from the resubmission, depending on the classification.”

Milestone describes etripamil as a novel calcium channel blocker nasal spray. “It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight,” it 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