Drugs

FDA Denies Novartis’ Entresto Petition

FDA has denied a 4/2019 Novartis petition asking the agency to take specified steps regarding ANDAs that reference the company’s Entresto (sacubitril and valsartan tablets). The agency’s 5/28 denial letter says Novartis asked FDA to:

require ANDAs that reference Entresto to demonstrate active ingredient sameness based on the chemical structure of the sacubitril and valsartan active ingredients present in the finished dosage form in ionic coordination with sodium with 1:1:3 stoichiometry;
revise the draft product-specific guidance on sacubitril and valsartan oral tablets to recommend that active ingredient sameness be established by showing that the chemical structure of each active ingredient in the finished dosage form of a proposed generic is identical to the chemical structure of each active ingredient in the reference-listed drug, including all ionic bonds; and
further revise the draft product-specific guidance as specified in the petition.

FDA says it disagrees with Novartis’ contention that applicants should be required to establish active ingredient sameness in the manner sought by the company and also disagrees that revised bioequivalence recommendations for sacubitril and valsartan tablets are necessary at this time. The letter makes these points:

proposed generics need not match the coordinated ionic structure of the active ingredients in Entresto to satisfy the sameness of active ingredients requirement; and
the draft sacubitril/valsartan product-specific guidance is consistent with the agency’s current recommendations for demonstrating bioequivalence of sacubitril and valsartan tablets.

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