AstraZeneca Pharma India Ltd on Monday said it has received approval from drug regulator CDSCO to import and distribute cancer treatment medicine Durvalumab solutions in the country.
The approval by the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India is for import, for sale and distribution of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) for an additional indication, the company said in a regulatory filing.
Durvalumab in combination with Tremelimumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC), it added.
The receipt of this permission paves way for the marketing of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) in India for the specified additional indication, subject to the receipt of related statutory approvals, the company said.