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FDA delays approval of new drug application for empagliflozin

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The FDA has issued a response letter to Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company regarding its new drug application for the type 2 diabetes drug, empagliflozin.

The FDA response letter cited deficiencies observed at a Boehringer Ingelheim drug manufacturing facility that need to be resolved before the application can be approved. The companies were not asked to complete any new clinical trials in the response letter from the FDA.

The sodium glucose co-transporter-2 inhibitor is being investigated for the reduction of blood glucose levels in adults with type 2 diabetes. The new drug application was based on findings from more than10 multinational clinical trials and over 13,000 participants with type 2 diabetes.