Ivacaftor tablet
Form: Tablets
Strength: 150 mg
Reference Brands: Kalydeco®(US & EU)
Category: Orphan Drugs
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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