Product/Composition:- | Voxelotor tablets |
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Strength:- | 500 mg |
Form:- | Tablet |
Reference Brands:- | Oxbryta(US) |
MOQ | As per the manufacturer batch size |
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Voxelotor inhibits hemoglobin S polymerization by binding to hemoglobin, increasing its oxygen affinity. This reduces sickling of red blood cells, decreasing hemolysis and improving anemia. Benefits include raising hemoglobin levels, reducing sickle cell crises, and enhancing quality of life for patients with sickle cell disease.
Voxelotor, marketed as Oxbryta, is approved in the US by the FDA for treating sickle cell disease. In the EU, regulatory approval is pending or under review. Approval requires a comprehensive dossier including clinical trial data, safety, efficacy, pharmacovigilance, and manufacturing details. In the US, submission involves detailed clinical study review, while the EU follows EMA guidelines for authorization. For guidance on dossier preparation, regulatory pathways, and successful market entry strategies, visit PharmaTradz. Ensuring compliance with regional regulations is essential for the safe, approved, and effective use of voxelotor worldwide, supporting patients with sickle cell disease.