Drugs

D.C. Federal Court Backs ‘Carve-Out’ Label

The D.C. federal court has rejected a Novartis suit challenging FDA’s approval of MSN’s ANDA for a generic version of Entresto (sacubitril /valsartan) with a carve-out of a patent-protected use. Attorney Sara Koblitz (Hyman, Phelps & McNamara) says MSN carved out a modified dosing regimen for patients not taking other heart failure drugs.

Novartis argued that the carve-out was improper, she says, as it both rendered the product less safe and effective than the reference-listed drug and impermissibly added words to the indication statement rather than simply omitting words as permitted by law.

It asked the court to resolve two questions: whether FDA-approved labeling for generic Entresto impermissibly deviated from the Entresto label and whether FDA unreasonably concluded that the generic drug had the same active ingredients as Entresto.

In rejecting Novartis’ claims, the court relied on FDA’s scientific expertise in determining how best to consider the ANDA labeling.

Koblitz concludes that Novartis gave the court “no reason to question FDA’s expert judgment regarding these scientific issues.”

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