pharmaphorum2d
Vertex gaining momentum with Kalydeco
Kalydeco was initially approved in 2012 to treat patients aged over six with a single mutation of the cystic fibrosis transmembrane regulator (CFTR) gene - known as G551D - which affects around ...
pharmaphorum6y
US regulators expand label for Vertex's Kalydeco CF drug
US regulators have expanded the label for Vertex’s cystic fibrosis drug, Kalydeco, extending its use to include children aged 12-24 months with certain genetic mutations. The FDA said Kalydeco ...
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 News28d
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 ...
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 ...