Drugs

Phathom Plans to Resubmit NDA, and Supplemental NDA

Phathom Pharmaceuticals says it will resubmit by the end of June an NDA for vonoprazan for treating erosive esophagitis, and a post-approval supplement for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin). In February, FDA sent two complete response letters related to the submissions that cited specifications and controls for a nitrosamine drug substance-related impurity, N-nitroso-vonoprazan (NVP), that was detected by the company (see earlier story).

“Since first detecting trace levels of NVP, Phathom conducted extensive root cause investigations and implemented mitigation measures, including a minor tablet reformulation, to inhibit the growth of NVP,” the company says. It has shared with FDA additional stability data on the reformulation and received feedback on the resubmission requirements, including the expected stability data requirements. “Based on this input, Phathom anticipates resubmitting the NDA for erosive esophagitis in the second quarter of 2023 which, if approved, could lead to a combined commercial launch of the erosive esophagitis and H. pylori indications in the fourth quarter of 2023,” 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