Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug applications for Liraglutide Injection single-patient-use prefilled pens and Glucagon for injection vials.
Both the products will be manufactured at the company’s injectable facility in Nagpur, Lupin said.
Liraglutide injection 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen is bioequivalent to Novo Nordisk’s Victoza injection and had an estimated annual sale of $458 million in the U.S, the company said citing IQVIA MAT May numbers. The drug is indicated to improve glycaemic control in adults and children, aged above 10 years, with type 2 diabetes mellitus.
Glucagon for Injection USP, 1 mg/vial, is bioequivalent to Eli Lilly and Company’s Glucagon for Injection, 1 mg/vial. It is indicated for treatment of severe hypoglycaemia in paediatric 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. It had an estimated annual sale of $124 million in the U.S.
Chief Scientific Officer Shahin Fesharaki said the two products are a meaningful enhancement to the company’s portfolio.
