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 ...

This means that the lumacaftor-Kalydeco combination could have an even greater commercial potential than Kalydeco's current licensed use, although analysts doubt it can show the same level of ...

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 ...

In March 2022, the Competition Commission launched an investigation into Vertex, alleging excessive pricing and exclusionary practices in its supply of cystic fibrosis drugs, including Kalydeco ...

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 ...

Read also: Safety of Lupin's Ranibizumab (Ranieyes) established in Large-Scale Multicenter Study with 2194 injections in 1401 eyes Ivacaftor Oral Granules, 25 mg, 50 mg and 75 mg (RLD Kalydeco) had an ...