Biocon Pharma Subsidiary Gets US FDA Approval for Liraglutide Injection ANDA
Biocon Pharma Limited, a subsidiary of Biocon Limited, received US FDA approval for its ANDA for Liraglutide Injection (gVictoza®). This follows a prior approval for Liraglutide injection (gSaxenda®) on February 24, 2026. The approval strengthens Biocon's complex drug product portfolio.
FDA approval for a drug product is a significant milestone that can lead to market entry and revenue generation, impacting the company's business and future prospects.
The US FDA approval for a new drug product signifies a positive development for the company's subsidiary and strengthens its product portfolio.
Biocon Limited announced that its wholly-owned subsidiary, Biocon Pharma Limited, has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Liraglutide Injection (gVictoza®), 18 mg/3 mL (6 mg/mL), Single-Patient-Use Prefilled Pens. Liraglutide is used for treating inadequately controlled Type 2 Diabetes Mellitus in adults, adolescents, and children aged 10 years and above, as a supplement to diet and exercise.
This approval follows the earlier approval for Liraglutide injection (gSaxenda®) received by the company on February 24, 2026. This development is expected to enhance Biocon's existing portfolio of complex drug products that are vertically integrated. The company's website, www.biocon.com, will also host this information.
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