Pharm'Up 
Global pharmaceutical leader Lupin Limited has reached a pivotal regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval for its Dapagliflozin and Metformin Hydrochloride Extended-Release (ER) Tablets.
The approval confirms that Lupin’s generic formulation is bioequivalent to the brand-name drug Xigduo® XR, providing a more accessible treatment option for patients managing type 2 diabetes.
Approval Details and Strengths
The FDA’s action covers a comprehensive range of dosages to meet diverse patient needs:
- Final Approval: 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg.
- Tentative Approval: 2.5 mg/1,000 mg.
Strategic Impact
As a major player in the “complex generic” space, this approval reinforces Lupin’s dominance in the chronic care segment. The combination therapy—utilizing an SGLT2 inhibitor (Dapagliflozin) and a biguanide (Metformin)—is a critical tool for healthcare providers in the U.S., where Lupin already maintains a strong footprint in respiratory and cardiovascular medicine.
By launching this bioequivalent version, Lupin continues to execute its strategy of bringing high-quality, affordable specialty medicines to the global market.
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