Hyderabad: Global pharma major Lupin Limited (Lupin) on Thursday 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 pack, 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, the pharma company said in a release.
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).
UNI
