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.’
You may also be interested in...
In granting GlaxoSmithKline’s motion for summary judgment in multidistrict litigation, judge notes FDA rejected requests to change warning label about use in pregnant women multiple times and would not have approved warnings sought by plaintiffs.
Agency officials meet with GSK and plaintiffs' steering committee in wake of GSK citizen petition; judge asks FDA to resolve petition 'expeditiously' as it could impact resolution of preemption dispute and the outcome of the litigation alleging Zofran caused birth defects.
The shingles vaccine could potentially be used in about three million immunocompromised people, according to GSK, but CDC’s advisory committee will weigh in with recommendations.