GSK Cited for Omitting Avandia Studies

-FDA News

04/10/2008- When GlaxoSmithKline’s (GSK) incoming CEO Andrew Witty takes the helm next month, he will have to deal with fallout from drug safety concerns surrounding Avandia, which have expanded to include a new FDA warning letter.

The FDA cited GSK for not reporting several postmarketing studies testing Type 2 diabetes treatment Avandia (rosiglitazone maleate). The drug’s sales have plummeted due to safety concerns.

The warning letter, issued March 25 and posted on the FDA’s website this week, cited GSK for not including information on Avandia postmarketing clinical trials in NDA annual reports between 2001–2007. It was addressed to GSK’s current CEO, Jean-Pierre Garnier.

GSK notified the FDA of 11 postmarket trials but not in annual reports, the letter said. However, the agency has no records for an additional nine trials before the company filed an amended NDA annual report last September, according to the warning letter.

The letter can be accessed at www.fda.gov/foi/warning_letters/s6714c.pdf and was issued by the FDA’s Atlanta district.

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