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Accord’s 12-Year-Old Prograf Generic Has US Equivalence Rating Pulled

FDA Funded Studies Reveal Increased Risk Of Toxicity For Accord’s Transplant Drug

Executive Summary

Accord Healthcare has been told by the FDA that its generic version of Astellas Pharma’s Prograf capsules will no longer be automatically substituted for the brand following a series of post-approval studies dating back more than a decade.

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