CDSCO Approves AstraZeneca's Fasenra for Hypereosinophilic Syndrome in India
Bengaluru: AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services (DGHS), Government of India, to import for sale and distribution Benralizumab 30 mg/ml solution for injection in a pre-filled syringe (Brand name: Fasenra) for an additional indication.
Through the approval, Benralizumab (Fasenra) 30 mg/ml solution for injection in a pre-filled syringe has been approved for the treatment of patients aged 12 years and older with Hypereosinophilic Syndrome (HES) who do not have an identifiable non-haematologic secondary cause. The approval expands the approved indication of the biologic therapy in India to include this patient population.
The company stated that the receipt of the CDSCO permission paves the way for the marketing of Benralizumab 30 mg/ml solution for injection in a pre-filled syringe (Brand name: Fasenra) in India for the specified additional indication. However, AstraZeneca clarified that the marketing of the product for the new indication will remain subject to the receipt of related statutory approvals, if any, before commercialization.
The regulatory approval was granted by the Central Drugs Standard Control Organization (CDSCO) functioning under the Directorate General of Health Services (DGHS), Government of India, allowing AstraZeneca Pharma India to proceed with the regulatory process for making the therapy available in the country for the newly approved indication.
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