Lupin gains US FDA approvals for Liraglutide and Glucagon Injectable Products
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
Lupin announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications for Liraglutide Injection Single-Patient-Use Prefilled Pens and Glucagon for Injection vials. Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India.
Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen is bioequivalent to Victoza Injection, 18 mg/3 mL (6 mg/mL) of Novo Nordisk. It 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. Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen (RLD Victoza) had an estimated annual sale of USD 458 million in the US (IQVIA MAT May 2025).
Glucagon for Injection USP, 1 mg/vial, packaged in an emergency kit1, is bioequivalent to Glucagon for Injection, 1 mg/vial of Eli Lilly and Company. It is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus and as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Glucagon for Injection USP, 1 mg/vial, had an estimated annual sales of $ 124 million in the US (IQVIA MAT May 2025).