Regulatory16 Jul 2026, 02:26 pm
AstraZeneca Pharma India Gets CDSCO Approval for Fasenra®
AI Summary
AstraZeneca Pharma India Limited has received approval from the Central Drugs Standard Control Organization (CDSCO) to import for sale and distribution of Benralizumab 30 mg/ml solution for injection (Brand name: Fasenra®). This approval is for an additional indication: treatment of patients aged 12 years and older with Hypereosinophilic Syndrome (HES) without an identifiable non-haematologic secondary cause. The receipt of this permission allows for the marketing of Fasenra® in India for this specific indication, subject to further statutory approvals.
Key Highlights
- CDSCO approval granted for Fasenra® import and sale in India.
- Approval is for an additional indication: Hypereosinophilic Syndrome (HES).
- Indication covers patients aged 12 years and older with HES.
- Paves way for marketing Fasenra® for the specified HES indication.
- Subject to receipt of related statutory approvals.
Price Impact
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