Biocon Pharma Limited, a subsidiary, has secured approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Liraglutide Injection (gVictoza®), a single-patient-use prefilled pen formulation (18 mg/3 mL). This approval covers the treatment of insufficiently controlled Type 2 Diabetes Mellitus in adults and children aged 10 and above. This follows a prior approval for the gSaxenda® formulation, further bolstering Biocon’s complex drug product portfolio in the crucial U.S. market.
Key Regulatory Milestone Achieved
Biocon announced on March 12, 2026, that its wholly-owned subsidiary, Biocon Pharma Limited, has received crucial approval from the U.S. Food and Drug Administration (U.S. FDA). This approval pertains to the company’s Abbreviated New Drug Application (ANDA) for Liraglutide Injection (gVictoza®).
Product Details and Indication
The approved product is a 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen. Liraglutide is indicated for use in patients suffering from insufficiently controlled Type 2 Diabetes Mellitus. The target patient population includes adults, adolescents, and children aged 10 years and above, administered as an adjunct to diet and exercise.
Portfolio Strengthening
This regulatory success builds upon a previous achievement. The company had already received approval for the Liraglutide injection marketed as (gSaxenda®) on February 24, 2026. Management noted that these approvals will significantly strengthen Biocon’s overall portfolio of vertically integrated, complex drug products, enhancing market competitiveness.
Regulatory Filings Context
The notification was submitted to the stock exchanges, referencing Scrip Code – 532523 and Scrip Symbol – Biocon, ensuring full compliance with disclosure requirements.
Source: BSE
