Latest news with #GlucagonforInjection
The Hindu
24-07-2025
- Business
- The Hindu
Lupin gets U.S. FDA nod for two generic diabetes drugs
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.
News18
24-07-2025
- Business
- News18
Lupin gets USFDA nod for generic diabetes drugs
Agency: PTI New Delhi, Jul 24 (PTI) Drug maker Lupin on Thursday said it has received approval from the US health regulator to market generic medications to treat diabetes. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug applications for Liraglutide Injection single-patient-use prefilled pens and glucagon for injection vials, the drug maker said in a statement. Both the products will be manufactured at the company's injectable facility in Nagpur, it added. Liraglutide Injection, 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen is bioequivalent to Novo Nordisk Inc's Victoza Injection. 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. As per IQVIA MAT May 2025 data, the injection had an estimated annual sale of USD 458 million in the US. Glucagon for Injection USP, 1 mg/vial, packaged in an emergency kit1, is bioequivalent to Eli Lilly and Company's Glucagon for Injection, 1 mg/vial. It is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. Glucagon for Injection USP, 1 mg/vial, had an estimated annual sale of USD 124 million in the US. 'This is a meaningful enhancement to our portfolio and reaffirms our commitment to expanding access to critical therapies for our patients," Shahin Fesharaki, Chief Scientific Officer, Lupin said. Lupin shares were trading 0.94 per cent up at Rs 1,938.50 apiece on BSE. PTI MSS MSS ANU ANU view comments First Published: July 24, 2025, 14:00 IST Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
