Empagliflozin NDA Resubmitted to FDA

Empagliflozin NDA Resubmitted to FDA
Empagliflozin NDA Resubmitted to FDA

Boehringer Ingelheim and Eli Lilly and Company announced the resubmission of a New Drug Application (NDA) to the FDA for the empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor for the treatment of adults with type 2 diabetes. The SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney.

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The Class 1 resubmission follows a Complete Response Letter issued by the FDA that referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA did not ask Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.

For more information visit Boehringer-Ingelheim.com or Lilly.com.

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