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For type 2 diabetes mellitus. ANDA 215503, held by Hikma. Liraglutide.
As of Nov 15, 2026, ANDA 215503 (Liraglutide), held by Hikma, was first approved by FDA on Dec 23, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Dec 23, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Liraglutide injection is indicated:
as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus Limitations of Use: Liraglutide injection should not be used in patients with type 1 diabetes mellitus. Liraglutide injection contains liraglutide and should not be coadministered with other liraglutide-containing products.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
