AstraZeneca Pharma India Ltd. has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and sell Durvalumab Solution for Infusion (Imfinzi) for an additional indication in India.
The approval covers two dosage forms: 120 mg/2.4 ml and 500 mg/10 ml. As per the new indication, Imfinzi can be used in combination with gemcitabine and cisplatin as a neoadjuvant treatment, followed by single-agent Imfinzi as an adjuvant treatment after radical cystectomy. This is indicated for adult patients diagnosed with muscle invasive bladder cancer (MIBC).
With this clearance, AstraZeneca can proceed to market Imfinzi for this indication in India, pending any additional regulatory approvals that may be required.
In the meantime, AstraZeneca Pharma India shares closed at ₹9,194.50 on July 14. The stock opened at ₹9,200.00 and touched an intraday high of ₹9,303.00 and a low of ₹9,161.00. The company’s 52-week high stands at ₹10,691.00, while the 52-week low is ₹6,220.00.
