Tag: Jardiance

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FDA Approves Glyxambi, New Type 2 Diabetes Medication 

The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company’s Glyxambi for treatment of adults with type 2 diabetes. Glyxambi is the first and only diabetes treatment in the U.S. to combine the dual mechanisms of ....
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FDA Issues Complete Response Letter for Type 2 Diabetes Drug Empagliflozin

The FDA has issued a complete response letter to Boehringer Ingelheim and Eli Lilly for the New Drug Application (NDA) of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin. The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured.
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