Lupin receives US FDA tentative approval for Ivacaftor Oral Granules

Global pharmaceutical giant Lupin has announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Ivacaftor Oral Granules.

 

These granules, available in 25 mg, 50 mg, and 75 mg per unit dose packets, are a generic equivalent of Kalydeco Oral Granules, manufactured by Vertex Pharmaceuticals Incorporated.

 

Lupin’s exclusive first-to-file status for this product may make it eligible for 180 days of generic drug exclusivity. The product will be manufactured at Lupin’s Nagpur facility in India.

 

Ivacaftor Oral Granules are prescribed for the treatment of cystic fibrosis, a genetic disease that causes the body to produce thick mucus, in patients aged four months and older who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that responds to ivacaftor.

 

 

According to IQVIA MAT data from November 2024, the Reference Listed Drug (RLD) Kalydeco had an estimated annual sale of $51 million in the U.S. Lupin’s aim with this entry is to provide a cost-effective alternative to patients and healthcare providers.