Drugs

Exelixis Wants 505(b)(2) Cabometyx Restrictions

Exelixis, which holds an NDA for Cabometyx (cabozantinib (S)-malate), a kinase inhibitor approved for several oncology indications, is asking FDA to impose restrictions on Handa Pharmaceuticals and any other companies submitting a 505(b)(2) NDA that references Cabometyx oral tablets. An Exelixis petition says Handa’s proposed cabozantinib product includes a different cabozantinib salt and differs in pharmacokinetics and manufacturing process compared to Cabometyx, “raising new questions of safety and efficacy that may put patients at increased risk and that cannot be resolved solely by relying on FDA’s approval of Cabometyx.”

The petition asks FDA to:

refuse to approve the Handa 505(b)(2) cabozantinib lauryl sulfate product and any cabozantinib lauryl sulfate products with similar genotoxic impurities and bioequivalence deficiencies, because available evidence shows that the salt switch has resulted in significant changes that are likely to raise novel questions of safety and effectiveness; and
require Handa and similarly submitted 505(b)(2) applicants to submit adequate data demonstrating safety and effectiveness.

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