GSK Settles Hundreds Of Avandia Suits Before FDA Advisory Cmte. Meeting
The upcoming FDA advisory committee meeting on Avandia (rosiglitazone) may be putting pressure on GlaxoSmithKline to settle a chunk of the product liability suits facing the company
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Two advisory panels recommended that FDA allow the trial of GlaxoSmithKline's Avandia (rosiglitazone) to continue but questioned its design, providing important hints for drug companies planning post-marketing safety trials in the future.
Company's internal e-mails suggest GSK hid vital studies related to safety of Avandia relative to competitor, senators charge.
Advisors could recommend that GlaxoSmithKline's diabetes drug be taken off the market, that the warnings on its label be downgraded, or a range of in-between options.