Zofran Birth Defect Defendant Files FDA Citizen Petition As Part Of Preemption Bid

Mealey's (November 20, 2019, 1:48 PM EST) -- BOSTON — GlaxoSmithKline LLC (GSK) on Nov. 1 filed a citizen petition asking the Food and Drug Administration for an opinion about Zofran’s birth defect warnings, a move that plaintiffs in the multidistrict litigation in a Nov. 13 brief say is designed to delay an upcoming bellwether trial but that GSK says in its own Nov. 13 brief will help the court decided whether the plaintiff’s claims are preempted (In Re:  Zofran [Ondansetron] Products Liability Litigation, MDL Docket No. 2657, No. 15-md-2657, D. Mass.)....

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