Drug maker Lupin said on Thursday that the approval was received by the American health ruler to market generic medicines to treat diabetes.
The company has received approval from the US Food and Drug Administration (USFDA) for its shortened new drug applications for liraglutide injection injection with one patient use pre-filled pens and glucagon for injection lacons, the medicine maker said in a statement.
Both products will be manufactured in the injectable facility of the company in Nagpur, it added.
Liraglutide injection, 18 mg/3 ml (6 mg/ml) Pre-filled pen With one patient is the bio-equivalent of the Victoza injection of Novo Nordisk Inc.
It is indicated as a supplement to diet and exercise to improve glykemic control in adults and pediatric patients from 10 years and older, with type 2 diabetes mellitus.
According to the IQVIA Mat May 2025 data, the injection had an estimated annual sale of $ 458 million in the US.
Glucagon for injection USP, 1 mg/vial, packed in an emergency kit1, is the bio -equivalent of Eli Lilly and the glucagon of the company for injection, 1 mg/vial.
It is indicated for the treatment of severe hypoglycaemia in pediatric and adult patients with diabetes mellitus.
Glucagon for injection USP, 1 mg/vial, had an estimated annual sale of $ 124 million in the US.
“This is a meaningful improvement of our portfolio and confirms our dedication to expand access to critical therapies for our patients,” said Shahin Fesharaki, Chief Scientific Officer, Lupine.
Lupine shares traded 0.94 percent higher at £ 1,938.50 each on BSE.
Published July 24, 2025
#Lupin #usfda #nod #generic #diabetes #medicines