Lumacaftor + Ivacaftor tablets
Form: Tablets
Strength: 200 mg lumacaftor + 125 mg ivacaftor
Reference Brands: Orkambi®(US & EU)
Category: Orphan Drugs
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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