Drugs

FDA Denies Glaxo Zofran Petition

FDA has denied without comment an 11/1/19 GlaxoSmithKline petition asking that the agency review four categories of information concerning the use of Zofran (ondansetron) in pregnancy and “either refrain from taking action to alter Zofran’s pregnancy-related labeling or take action to alter the labeling in light of these four categories of information, as the agency deems appropriate.” The FDA response denies the petition without comment on the relevance, if any, of the information to ondansetron product labeling.

“FDA evaluates whether safety-related labeling changes are warranted based on the review of all relevant information available to the agency,” the response says. “Your request that FDA review and opine on certain pieces of information to answer a hypothetical question separate and apart from FDA’s ongoing product review would divert scientific staff time away from pending drug applications, drug product safety review, and other work critical to our public health mission and therefore would detract from fulfilling the agency’s statutory obligations.”

The response contains background information on safety-related labeling for prescription drugs that FDA says may help clarify its expectations for application holders’ submission of postmarketing safety-related information in the context of relevant statutory and regulatory requirements.

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