AstraZeneca Pharma India Ltd. has got approval from the Central Drugs Standard Control Organisation to import for sale and distribution of Durvalumab solution, according to an exchange filing on Monday.
"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," the filing stated.
"Through this approval, Imfinzi, in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer," it said.
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 in India, depending on the related statutory approvals.
In March, the company had received approval from the drug regulator to import and sell sodium zirconium cyclosilicate powder for oral suspension, used to treat hyperkalemia — high potassium levels in the blood — in adults, according to an exchange filing.
The CDSCO has granted permission to import pharmaceutical formulations of sodium zirconium cyclosilicate powder for oral suspension in 5 g and 10 g doses (Lokelma).
Shares of AstraZeneca closed 0.62% lower at Rs 9,184.50 apiece on the National Stock Exchange before the announcement, compared to a 0.27% decline in the benchmark Nifty. The share price has risen 36.06% in the last 12 months and 25.73% on a year-to-date basis.
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