Drugs

Court Tosses Novartis Entresto Suit Against FDA

The DC federal court has granted summary judgment to FDA and MSN Pharmaceuticals, the defendants in a suit filed by Novartis claiming the agency violated the Administrative Procedure Act, the Federal Food, Drug, and Cosmetic Act, and its implementing regulations by approving an MSN application to market a generic form of Novartis’ heart failure drug Entresto. The court held that MSN’s generic drug was consistent with FDA regulatory and statutory requirements that require a generic drug to have the same label and active ingredients as the reference-listed drug. It also held that FDA did not act arbitrarily by excluding part of Entresto’s dosing regimen from the MSN generic drug label.

In its decision, the court supported FDA’s actions in approving an indication carveout and a dosing regimen carveout. It also deferred to FDA’s factual determination that Entresto and the MSN generic contain the same two active ingredients—sacubitril sodium and valsartan disodium. “Because FDA’s determination that Entresto and MSN’s generic contain the same active ingredients was rational, carefully explained, and consistent with the record evidence, the court will not ‘unduly second-guess’ its ‘scientific judgment,’” the court 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