Lupin Gets USFDA Nod for Liraglutide, Glucagon Injectables

Approval has been received by Lupin Limited 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.  Lupin Injectable facility is manufacturing both of these products

Injection of Liraglutide, 18 mg/3 mL (6 mg/mL) Single-Patient-Use The prefilled pen is bioequivalent to Novo Nordisk Inc.'s Victoza® Injection, 18 mg/3 mL (6 mg/mL). It is recommended as a supplement to diet and exercise to help adults and children with type 2 diabetes mellitus who are 10 years of age or older achieve better glycemic control. Injection of Liraglutide, 18 mg/3 mL (6 mg/mL) The expected yearly sales of RLD Victoza, a single-patient-use prefilled pen, in the United States were USD 458 million (IQVIA MAT May 2025).

Glucagon for Injection USP, 1 mg/vial, packaged in an emergency kit, is considered bioequivalent to Glucagon for Injection, 1 mg/vial of Eli Lilly and Company. The treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus is indicated, as well as its use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. An estimated annual sale of US$ 124 million in the U.S. (IQVIA MAT May 2025) was reported for Glucagon for Injection USP, 1 mg/vial.

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Dr. Shahin Fesharaki, Chief Scientific Officer, Lupin said, “We are pleased to obtain the USFDA approvals for two of our complex injectable products. This is a meaningful enhancement to our portfolio and reaffirms our commitment to expanding access to critical therapies for our patients.”