Boehringer Ingelheim, Eli Lilly Receive FDA Complete Response Letter for Manufacturing Issues with EmpagliflozinBy
Boehringer Ingelheim Pharmaceuticals Inc.and
The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured.
“Boehringer Ingelheim and Lilly are committed to working with the
Empagliflozin is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds and is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.
Source: Eli Lilly and Company