FDA rejects BI 10773 NDA for Type 2 Diabetes - Boehringer/Lilly
Boehringer Ingelheim and Eli Lilly have announced that the FDA has issued a complete response letter for the New Drug Application (NDA) of BI 10773 (empagliflozin) for treating Type 2 Diabetes. The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA stated these deficiencies need to be resolved before the approval of the application. The FDA has not asked Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.
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