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Lupin Announces FDA Approval for Dapagliflozin Tablets
The generic version of Farxiga is now available in the U.S. market.
Apr. 8, 2026 at 5:50am
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The FDA's approval of a generic version of the diabetes medication dapagliflozin will provide patients with a more affordable treatment option.Naples TodayLupin Limited, a global pharmaceutical leader, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Dapagliflozin Tablets, 5 mg and 10 mg. The tablets are bioequivalent to Farxiga, a popular diabetes medication.
Why it matters
The approval of Lupin's generic version of Dapagliflozin Tablets will provide patients with a more affordable treatment option for managing their diabetes, potentially improving access and adherence to this important medication.
The details
Lupin's Dapagliflozin Tablets, 5 mg and 10 mg, have been approved by the FDA as bioequivalent to Farxiga, the branded version of the drug. This means the generic version will have the same active ingredients, strength, dosage form, and route of administration as the original, allowing it to be substituted for the brand-name drug.
- Lupin received FDA approval for the Dapagliflozin Tablets on April 7, 2026.
The players
Lupin Limited
A global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
U.S. Food and Drug Administration (FDA)
The federal agency responsible for regulating and supervising the safety of food, drugs, and other products in the United States.
Farxiga
A branded diabetes medication developed and marketed by AstraZeneca AB.
What’s next
Lupin's Dapagliflozin Tablets are expected to be available in the U.S. market in the coming months, providing patients with a more affordable alternative to the branded Farxiga product.
The takeaway
The FDA's approval of Lupin's generic Dapagliflozin Tablets represents an important step in increasing access to affordable diabetes treatments, which can have a significant impact on patient health outcomes and the overall cost of healthcare.
