Lupin Ltd Receives U.S. FDA Approvals for Liraglutide and Glucagon Injectable Products

Global pharma major Lupin Limited has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Applications for Liraglutide Injection Single-Patient-Use Prefilled Pens and Glucagon for Injection vials. These products will be manufactured at Lupin’s Injectable facility at Nagpur, India. 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. Glucagon for Injection 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. Liraglutide Injection had an estimated annual sale of USD 458 million in the U.S., while Glucagon for Injection had an estimated annual sale of USD 124 million in the U.S.