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Mylan Hits Back At ‘Misleading’ FDA Warning Letter

Claims Agency Warning Letter Contains ‘Misleading Information’ On Nitrosamines

Executive Summary

Mylan has hit back at “misleading information” circulating in connection with a recent FDA warning letter – including some statements within the letter itself – as it highlighted its proactive efforts in investigating “all potential risks associated with inquiries related to nitrosamine impurities.”

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