New Launch30 May 2025, 09:15 am
AstraZeneca Pharma India Receives Approval for Benralizumab for Additional Indication of EGPA
AI Summary
AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import and distribute Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) for an additional indication. This approval allows Benralizumab to be indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The marketing of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) in India for the specified additional indication is subject to the receipt of related statutory approvals, if any.
Key Highlights
- AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Government of India for an additional indication of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra)
- Benralizumab is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA)
- The marketing of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) in India for the specified additional indication is subject to the receipt of related statutory approvals, if any