Drugs

Court Nixes Restraining Order Request in Entresto Suit

The Washington DC District Court has denied a Novartis motion for a temporary restraining order or a preliminary injunction to stay FDA’s approval of MSN Laboratories’ generic version of Novartis’s Entresto (sacubitril/valsartan), indicated for reducing the risk of cardiovascular death and hospitalization in adult patients with chronic heart failure.

Novartis last month (see story) filed a lawsuit against FDA to reverse the generic’s approval, arguing that the agency’s conduct in approving the product and denying two citizen petitions submitted by Novartis was unlawful. “FDA has asserted that it may approve generic labeling that inappropriately rewrites Entresto’s approved indication and reverts to a superseded indication in an effort to avoid Novartis’s patents,” the lawsuit says. By doing this, Novartis says the agency violated its implementing regulations, which provide that generic labeling may omit an indication that is subject to patent rights, but not add wording or make other changes to an indication remaining in the labeling.

In seeking the temporary restraining order while the case advances, Novartis offered three theories of irreparable harm, but the court said “none of them rise to such imminence and severity as to meet this circuit’s ‘high bar’ for the ‘extraordinary remedy’ of preliminary injunctive relief.” It added that the court has committed to “resolving the merits of this action on an expedited basis — within the next 60 days or less — so any harm that Novartis purports to suffer will be short-lived.”

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