Product/Composition:- | Ivacaftor tablet |
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Strength:- | 150 mg |
Form:- | Tablets |
Reference Brands:- | Kalydeco®(US & EU) |
MOQ | As per the manufacturer batch size |
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Ivacaftor tablets enhance cystic fibrosis treatment by acting as a CFTR potentiator, increasing the activity of the defective CFTR protein caused by specific mutations. Benefits include improved lung function, better mucus clearance, and overall quality of life, making it a targeted therapy for eligible cystic fibrosis patients.
Ivacaftor tablets, marketed as Kalydeco®, are approved for cystic fibrosis treatment in the US and EU. Regulatory agencies like the FDA and EMA reviewed extensive clinical data and manufacturing dossiers for approval, ensuring safety, efficacy, and quality. These dossiers contain detailed information on clinical trials, pharmacology, and manufacturing practices. Kalydeco® is available in 150 mg tablets, offering targeted therapy for specific CF mutations. For expert insights on regulatory processes, dossier submissions, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory updates and industry analysis.