Drugs

Novartis Wants Restrictions on Entresto ANDAs

Novartis is petitioning FDA to take specified actions on any ANDAs citing its heart failure drug Entresto (sacubitril and valsartan) oral tablets as the reference-listed drug. The 9/12 petition asks that FDA:

refrain from approving any ANDA referencing Entresto during the three-year exclusivity period covering labeling changes approved in a 2/2021 supplement, including any ANDA that seeks to add language to or otherwise revise the existing indication statement to omit the exclusivity-protected use;
refrain from approving any ANDA for Entresto until the expiration of the HFpEF (preserved ejection fraction) patents if the ANDA contains a Section viii statement to the patents and seeks to omit the patent-protected use of the HFpEF patents; and
refrain from approving any ANDA for Entresto until the expiration of the ’667 patent if the ANDA contains a Section viii statement and seeks to omit the modified dosing regimen for HFpEF patients not taking an ACE inhibitor or ARB, or who were previously taking low doses of those agents.

Novartis says it believes at least 18 sponsors have submitted ANDAs seeking approval of a generic Entresto and it initiated timely patent litigation against them. “One or more of the ANDA applicants may seek approval during the three-year exclusivity period by proposing to omit the exclusivity-protected conditions of approval derived from the PARAGON-HF trial. These generic applicants may also seek to submit a Section viii statement to the three HFpEF patents along with a proposal to omit the labeling information claimed by these patents. In particular, one or more ANDA applicants may seek approval for an indication that omits the expanded patient population approved in 2/2021, which includes HFpEF patients, in favor of an indication statement limited to HFpEF patients…. FDA should refrain from approving such an ANDA product.”

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