Product/Composition:- | Lumacaftor + Ivacaftor tablets |
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Strength:- | 200 mg lumacaftor + 125 mg ivacaftor |
Form:- | Tablets |
Reference Brands:- | Orkambi®(US & EU) |
MOQ | As per the manufacturer batch size |
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Lumacaftor + Ivacaftor tablets treat cystic fibrosis by combining a CFTR corrector (lumacaftor) that improves protein folding and trafficking with a potentiator (ivacaftor) that enhances CFTR channel activity. Benefits include increased lung function, reduced symptoms, improved quality of life, and decreased hospitalization rates in eligible CF patients.
Lumacaftor + Ivacaftor tablets, marketed as Orkambi®, are approved by the FDA and EMA for cystic fibrosis treatment. Regulatory dossiers include comprehensive clinical trial data, manufacturing details, and safety profiles, supporting approval and market access. These dossiers demonstrate the therapy's efficacy in improving lung function and reducing CF symptoms. Orkambi® is available as a fixed-dose combination tablet, with 200 mg lumacaftor and 125 mg ivacaftor. For detailed insights on regulatory processes, dossier submissions, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory updates and industry analysis.