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Lupin Receives Tentative Approval from U.S. FDA for Ivacaftor Oral Granules
Mumbai, Naples, January 9, 2025: Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Ivacaftor Oral Granules, 25 mg, 50 mg, and 75 mg per unit dose packet, to market a generic equivalent of Kalydeco® Oral Granules, 25 mg, 50 mg, and 75 mg, of Vertex Pharmaceuticals Incorporated. Lupin is the exclusive first-to-file for this product and may be eligible for 180 days of generic drug exclusivity. This product would be manufactured at Lupin’s Nagpur facility in India.
Ivacaftor Oral Granules, 25 mg, 50 mg and 75 mg per unit dose packet are indicated for the treatment of cystic fibrosis (CF) in patients aged 4 months and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor.
Ivacaftor Oral Granules, 25 mg, 50 mg and 75 mg (RLD Kalydeco®) had an estimated annual sale of USD 51 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
Kalydeco® is a registered trademark of Vertex Pharmaceuticals Incorporated.
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