REGULATORY

Ministry Requires Addition of Thrombocytopenia as Serious ADR to Januvia

March 25, 2015
The Pharmaceutical and Food Safety Bureau’s Safety Division issued a director notification on March 24 requiring revisions to the precautions section of the package inserts of six active pharmaceutical ingredients (APIs) including the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin phosphate hydrate…

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REGULATORY

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