Lupin Cystic fibrosis drug gets tentative approval from USFDA
Ivacaftor Oral Granules, 25 mg, 50 mg and 75 mg per unit dose packet are indicated for cystic fibrosis treatment in patients aged 4 months and older.
Mumbai: Global pharma major, Lupin Limited, has announced that the Company 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. The company has 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 workforce of over 22,000 professionals.
