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 ...
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).
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Lupin Receives Tentative USFDA Approval For Generic Ivacaftor Oral Granules
These generic granules are equivalent to Vertex Pharmaceuticals' 'Kalydeco' oral granules in the same strengths. "Lupin is the exclusive first-to-file for this product and may be eligible for 180 days ...
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 ...
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.
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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 ...