Lupin gets USFDA nod for generic diabetes drugs

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