Valisure Puts FDA Under Microscope In Complaint On Ranitidine Tests Seeking Damages From GSK

Amended complaint filed 21 May after US Attorney General in March said the federal and state governments, named as co-plaintiffs, wouldn’t intervene and the court ordered the complaint unsealed. Complaint, initially filed in 2019, is critical of FDA, generally alleging agency failed to conduct sufficient oversight and evaluation of GSK’s testing data for ranitidine.

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The curtain’s lifted on Valisure LLC’s next act after finding troubling levels of a carcinogen in popular drug ingredient ranitidine with the unsealing of its complaint alleging federal and state false claims law violations by GSK plc, the US marketer of the top OTC brand formerly using the ingredient.

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