Eliglustat capsule

Form: Capsules

Strength: 84 mg

Reference Brands: Cerdelga®(US & EU)

Category: Orphan Drugs

Eliglustat capsules, marketed as Cerdelga®, are approved for treating Gaucher disease type 1 in both the US and EU. The FDA and EMA reviewed comprehensive regulatory dossiers, including clinical trial data, manufacturing standards, and safety profiles, to ensure high-quality standards. These dossiers support regulatory approval and facilitate market access. Cerdelga® capsules are available in an 84 mg strength, offering an effective oral therapy option. For detailed information on the regulatory process, dossier submissions, and market approvals, visit PharmaTradz, your source for pharmaceutical regulatory insights and updates.