Eli Lilly, Boehringer Ingelheim Gain Tentative FDA Approval for Insulin Glargine ProductBy
The US Food and Drug Administration (FDA) has granted tentative approval for Basagla (insulin glargine injection),
Basaglar has the same amino acid sequence as the currently marketed insulin glargine product and was tentatively approved for use with KwikPen, a pre-filled dosing device. With a tentative approval, the
â€‹The Basaglar new drug application was filed through the
The tentative approval in the US is based, in part, on results from Lilly and Boehringer Ingelheim’s clinical development program for their insulin glargine product. The submission included results from pharmacokinetic and pharmacodynamics studies, as well as Phase III studies in people with Type 1 and Type 2 diabetes.
The trade name Basaglar was granted provisional approval by the
Source: Eli Lilly