Lupin Wins U.S. FDA Nod for Generic Dapagliflozin Tablets

Lupin Limited ( (IN:LUPIN) ) has issued an announcement.

Lupin Limited has secured U.S. Food and Drug Administration approval for its Abbreviated New Drug Application for Dapagliflozin Tablets in 5 mg and 10 mg strengths. The product has been deemed bioequivalent to AstraZeneca’s Farxiga for the indications in the approved labeling, positioning Lupin to participate in the sizeable U.S. market for anti-diabetic therapies.

The approval strengthens Lupin’s U.S. generic portfolio in a key metabolic segment where it already has a strong presence. The launch of a bioequivalent version of a leading SGLT2 inhibitor is expected to enhance the company’s competitive standing in cardiovascular and diabetes care, potentially benefiting patients and payers through increased treatment options and pricing pressure.

More about Lupin Limited

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products sold in more than 100 markets. The company develops branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients, and holds strong positions in India and the U.S. across therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.

Average Trading Volume: 27,536

Technical Sentiment Signal: Buy

Current Market Cap: 1041.4B INR

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