The Food and Drug Administration has given Lupin a tentative ... Lupin also received tentative approval from the FDA for ivacaftor oral granules, 25 mg, 50 mg and 75 mg per unit dose packet ...

Vanzacaftor-tezacaftor-deutivacaftor, a novel therapeutic, once-daily drug, demonstrates noninferiority to elexacaftor-tezacaftor-ivacaftor (the twice-daily, standard-of-care drug) in lung ...

Ivacaftor, an oral potentiator ... These 3 agents provide a promising start to a new age in CF treatment. All 3 drugs are formulated for oral administration, making medication adherence easier ...

carries nine heavy hydrogens that provide it with a reduced rate of clearance and a longer half-life than ivacaftor — enabling once-daily dosing. Vertex acquired the deuterated drug from Concert ...

These granules, available in 25 mg, 50 mg, and 75 mg per unit dose packets, are a generic equivalent of Kalydeco Oral Granules ...

with high-dose fluconazole), other drugs metabolized by CYP2C9, CYP2C19, and CYP3A4; monitor. Potentiates abrocitinib, lemborexant; avoid. Potentiates ivacaftor, fixed-dose ivacaftor combinations ...

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.

is for the abbreviated new drug application for Ivacaftor oral granules of strengths 25 mg, 50 mg, and 75 mg per unit dose packet, Lupin said in a statement. These are the generic equivalent of ...