GlaxoSmithKline Petitions FDA to Review Zofran Data

GlaxoSmithKline has petitioned the FDA to review clinical data on the use of its anti-nausea drug Zofran (ondansetron) during pregnancy.

The drugmaker is facing multiple lawsuits in a Massachusetts federal court alleging that Zofran’s labeling regarding pregnancy is “erroneous and misleading” — and that the company failed to fully inform the FDA of details that would have affected the labeling.

In its citizen petition, GSK urged the agency to “either refrain from taking action to alter Zofran’s pregnancy-related labeling or take action to alter the labeling” and explain which data warranted the labeling changes.