FDA approves Jentadueto XR from Boehringer Ingelheim, Lilly

SILVER SPRING, Md. — The Food and Drug Administration has approved Boehringer Ingelheim and Eli Lilly and Co.’s Jentadueto XR (linagliptin and metformin HCl) tablets, the companies announced Tuesday. 

 

The new drug is indicated as a once-daily adjunctive treatment for Type 2 diabetes and works by increasing hormones that stimulate insulin production in the pancreas and that stimulate the liver to produce less glucose. 

 

“Adults with type 2 diabetes are often required to take more than one medication to manage their condition, including some that have to be taken multiple times a day,” Boehringer Ingelheim president and CEO Paul Fonteyne. “Jentadueto XR, the first extended-release therapy to emerge from our alliance with Lilly, offers adults with type 2 diabetes the convenience of a combination pill taken once a day to help lower blood sugar levels.”

 

Jentadueto XR contains a boxed warning for the risk of lactic acidosis that can occur due to metformin accumulation. The drug will be available in dosage strengths with 2.5 mg of linagliptin and 1000 mg of metformin, as well as 5 mg of linagliptin and 1000 mg of metformin.