Drugs

FDA May Allow Novel Carve-Ins: Attorneys

Axinn attorneys Matthew Murphy and Aaron Savit say a recent regulatory decision on a generic form of Novartis’ chronic heart failure drug Entresto (sacubitril/valsartan) may signal some agency flexibility to consider novel carve-in labeling modifications as part of a Section viii skinny labeling strategy. Writing in an online post, the attorneys say that based on a later study following the drug’s approval, FDA approved an expanded patient population. The agency denied a petition asking that FDA not approve any ANDA seeking to exclude the newly added patient population using Section viii statements.

At least one ANDA filer has already been approved with such a carve-in, the attorneys say. They say the agency approach is consistent with an earlier decision involving a carve-in for a generic form of Takeda’s Velcade (borezumib).

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