Pharmabiz1mon
Lupin’s ivacaftor oral granules receives US FDA tentative approval
Ivacaftor oral granules, 25 mg, 50 mg and 75 mg (Kalydeco) had an estimated annual sale of USD 51 million in the US (IQVIA MAT November 2024).
Drug Store News1mon
FDA gives Lupin tentative OK for 2 generics
Lupin also received tentative approval from the FDA for ivacaftor oral granules, 25 mg, 50 mg and 75 mg per unit dose packet, which is a generic of Vertex’s Kalydeco. Lupin is the exclusive ...
money.rediff1mon
Lupin Gets USFDA Approval for Generic Cystic Fibrosis Treatment
Lupin receives USFDA approval for its generic version of Ivacaftor oral granules, a treatment for cystic fibrosis. The approval marks a significant step for Lupin in the US market.
Lupin receives US FDA tentative approval 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 ...
Hosted on MSN1mon
Lupin gets USFDA nod for generic cystic fibrosis treatment medicine
These are the 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 ...