Familes Blast GSK's New Zofran Label Submission In MDL
Law360, New York (October 6, 2016, 10:21 PM EDT) -- Families in multidistrict litigation over GlaxoSmithKline’s anti-nausea drug Zofran on Thursday told a Massachusetts federal court that a 2016 label update shows that it was, in fact, possible to show additional warnings on a previous label beyond what had been approved by regulators, contrary to the company’s assertions.
The updated label is “ironically” the first time that a Zofran label has ever disclosed that studies of the drug in pregnancy have reported an increased link between exposure to the drug and cardiovascular and cleft palate birth defects, the families said. GSK had submitted an updated label produced by the new label...
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