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 ...
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 ...
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 ...
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 ...
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