Drugs

Amneal Gets Approval for Parkinson’s Drug

FDA has approved an Amneal Pharmaceuticals NDA for Crexont (carbidopa and levodopa) extended-release capsules for treating Parkinson’s disease. The product is described as a novel oral formulation of carbidopa/levodopa that combines both immediate-release granules and extended-release pellets that are designed to provide a longer duration of good “on” with less frequent dosing compared to currently approved immediate-release formulations of carbidopa and levodopa. Good "on" time is defined as “on” time without troublesome dyskinesia as the disease progresses, the company says. The formulation is intended to remain in the small intestine for a longer period, helping it to be consistently absorbed, it adds.

Amneal resubmitted the NDA in February and it addressed issues raised in a 7/2023 complete response letter related to safety concerns, according to Amneal. “The resubmission package included data from a healthy volunteer study which was conducted in the fourth quarter of 2023,” it said at the time, adding that the agency did not request any other studies.

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