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These hearings result in an FDA advisory committee reviewing Nissen’s research and GSK’s interim RECORD study.The FDA ultimately allows Avandia to stay on the market with the addition of the FDA’s strictest “black-box” warning label.GSK releases a statement expressing confidence in Avandia.The New England Journal of Medicine publishes an editorial accusing GSK of tampering with the trial and hiring biased experts.Glaxo Smith Kline’s (GSK) controversial diabetes drug Avandia (generic name Rosiglitazone) works by helping diabetics balance their blood-sugar levels.

FDA researchers release a memo revealing that RECORD, the GSK-sponsored trial of Avandia, omitted crucial data and was therefore flawed.

An FDA advisory panel meets, recommends that the drug should stay on the market but with new label warnings and prescription restrictions.

New FDA Commissioner Margaret Hamburg gets final say on whether to enact this recommendation.

Nearly half a million people are taking the medication, which translates into approximately 0 million in annual sales.

Below is a Need to Know chronology highlighting Avandia’s history leading up to a big decision by the FDA on whether to pull it from the shelves.

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