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Westlaw News

FDA rejects GSK's request to weigh in on Zofran birth defect litigation

The U.S. Food and Drug Administration has rejected GlaxoSmithKline’s request to weigh in on a key question in lawsuits by women who say the drugmaker failed to warn them that taking the anti-nausea drug Zofran during pregnancy can cause birth defects.

The FDA in a letter dated Friday declined a request GSK made in November 2019 that asked the agency to consider whether certain studies and information the plaintiffs claim the drugmaker withheld from the regulator warranted a change to Zofran’s warning label.

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