News
Tirzepatide is filed at FDA and at EMA to treat type 2 diabetes.
Eli Lilly announced with its Q3 financial results that it has submitted a New Drug Application (NDA) to the FDA and a Marketing Authorization Application to the European Medicines Agency for tirzepatide for the treatment of adults with type 2 diabetes.
A Priority Review Voucher was applied to the NDA, leading to an anticipated review time of eight months from the date of submission according to current FDA priority review timelines. Several additional submissions are planned around the world before the end of 2021.
Condition: Diabetes Type 2
Type: drug
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