Biocon Secures USFDA Nod for Generic Liraglutide Prefilled Pens for Diabetes
New Delhi: Biocon Limited's wholly owned subsidiary Biocon Pharma Limited has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Liraglutide Injection (gVictoza) 18 mg/3 mL (6 mg/mL) in single-patient-use prefilled pens.
According to the company, Liraglutide is indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus in adults, adolescents and children aged 10 years and above. The therapy is used as an adjunct to diet and exercise to improve glycaemic control in patients whose diabetes is not adequately managed.
The company noted that the latest approval follows an earlier regulatory clearance received on February 24, 2026 for Liraglutide Injection (gSaxenda). Biocon stated that the approval will further strengthen its portfolio of vertically integrated, complex drug products.
The company added that the information regarding this development will also be made available on its official website. The update was shared with stock exchanges as part of a regulatory notification.
