Drugs

GSK Asks FDA Review of Zofran Information

GlaxoSmithKline is asking FDA to review four categories of information concerning the use of Zofran (ondansetron) in pregnancy and determine whether there should be any labeling changes. “GSK understands that FDA may be reviewing or will soon review, together with Zofran’s current NDA holder, Novartis, Zofran’s safety profile and labeling as a result of newly available epidemiological studies and an assessment of Zofran’s labeling by the Pharmacovigilance Risk Assessment Committee,” the petition says.

Glaxo says the four categories of information arose in lawsuits claiming that Zofran use in pregnancy causes birth defects. “The plaintiffs have claimed that GSK failed to fully inform FDA of four categories of information relating to Zofran, which they contend would have caused FDA to change Zofran’s pregnancy labeling,” the company says. “GSK believes that it complied with all regulatory disclosure requirements and that none of the cited information materially affects Zofran’s safety profile or labeling. Nevertheless, GSK respects FDA’s views on whether the four categories of information that the plaintiffs have identified contain any new and material information about Zofran. GSK also acknowledges that FDA has the authority to decide whether such information warrants inclusion in Zofran’s labeling.”

The company asks that the agency either refrain from taking action to change the drug’s pregnancy-related labeling or take action to change the labeling in light of the four categories of information, as FDA deems appropriate. If the labeling is to be changed, the company says, GSK asks that FDA inform it and the public which categories of information, if any, necessitated a labeling change, whether the agency believes it did not already have the information, and/or why the information is material to the agency’s labeling decision.

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