AstraZeneca Pharma India Ltd. on Monday announced that it has received nod from drug regulator Central Drugs Standard Control Organisation for the sale of cancer treatment medicine Durvalumab solutions.
The approval from CDSCO is for import, sale and distribution of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) for an additional indication, according to an exchange filing.
Durvalumab, in combination with Tremelimumab, is indicated for the treatment of patients with unresectable hepatocellular carcinoma or 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.
Shares of AstraZeneca Pharma closed 2.38% higher at Rs 6,858.20 apiece, compared to 0.02% decline in the benchmark NSE Nifty 50. The stock has risen by 25.86% in the last 12 months.
(With PTI inputs)
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