GSK Loses Bid To Get US FDA To Change Zofran Label, But May Prevail On Preemption Defense Anyway

Agency denies GlaxoSmithKline’s citizen petition requesting review of information about Zofran’s use in pregnancy. But GSK says agency has ‘clearly communicated its position that birth defect warnings are not warranted for Zofran.’

Zofran
FDA denied citizen petition seeking review of information on Zofran use in pregnancy • Source: Alamy

The US Food and Drug Administration gave remarkable consideration to GlaxoSmithKline plc’s citizen petition asking the agency to review information about use of the antiemetic Zofran (ondansetron) during pregnancy. But the agency ultimately denied the petition, saying the company was asking it to weigh in on a “hypothetical question.”

GSK filed the petition last year requesting that the agency consider four categories of information and either change or affirm...

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