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Lupin Receives U.S. FDA Approval for Sacubitril and Valsartan Tablets
Mumbai, Naples, January 24, 2025: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S.FDA) for its Abbreviated new Drug Application (ANDA), Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, the generic version of Entresto® Tablets, 24mg/26mg, 49 mg/51mg, and 97 mg/103 mg.
Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, the generic version of Entresto® Tablets, 24mg/26mg, 49 mg/51mg, and 97 mg/103 mg of Novartis Pharmaceuticals Corporation, are indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.
Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, had estimated annual sales of USD 6,061 million in the U.S. (IQVIA MAT November 2024).
Lupin Limited is 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. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. To know more, visit www.lupin.com or follow us on LinkedIn: https://www.linkedin.com/company/lupin
For further information or queries please contact –
Vice President & Global Head – Corporate Communications, Lupin
Entresto® is a registered trademark of Novartis AG
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