AstraZeneca India wins CDSCO approval for Durvalumab in cancer
New Delhi, Feb 10 : AstraZeneca Pharma India Limited on Tuesday said it has received permission from the Central Drugs Standard Control Organisation (CDSCO) to sell and distribute Durvalumab solution for infusion used in cancer treatment for an additional indication. In its latest stock exchange filing, the drug company said that through this approval, “Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with Durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)”. According to the filing, “This is to inform that AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Durvalumab Solution for Infusion 120 mg/2.4 mL and 500 mg/10 mL (Brand Name: Imfinzi) for an additional indication,” said AstraZeneca Pharma India Ltd.