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Monday, February 16, 2026 5:55 AM

regulatory approval

AstraZeneca Secures CDSCO Approval for Expanded Use of Imfinzi in Endometrial Cancer Treatment

AstraZeneca Pharma India Ltd announced on Tuesday (February 10, 2026) that it has obtained approval from India’s drug regulator to market its cancer therapy, Durvalumab (brand name Imfinzi), for an additional indication. In a regulatory filing, the company stated that the Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services, has granted permission to import, sell, and distribute Durvalumab solution for infusion in strengths of 120 mg/2.4 ml and 500 mg/10 ml for expanded therapeutic use. With this latest approval, Durvalumab can now be used in combination with chemotherapy drugs carboplatin and paclitaxel as a first-line treatment for adults diagnosed with primary advanced or recurrent endometrial cancer who are eligible for systemic therapy. Following combination treatment, the drug is also approved as a standalone maintenance therapy for patients with mismatch repair deficient (dMMR) endometrial cancer. The company noted that this regulatory clearance enables the commercial rollout of Imfinzi for the newly approved indication in India, subject to completion of other necessary statutory formalities. Source: PTI  

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Aurobindo Pharma Gets USFDA Approval for Icatibant Injection

 A significant achievement for Aurobindo Pharma emerges as its wholly-owned subsidiary, Eugia Pharma Specialities, gains the final green light from the US health authority for the production and distribution of a generic Icatibant injection. This injection is integral in addressing hereditary angioedema. The endorsement, bestowed by the US Food & Drug Administration (USFDA), pertains to the 30 mg/3 mL (10 mg/mL) strength of Icatibant injection, presented as a single-dose pre-filled syringe. Aurobindo Pharma disclosed this development through an official filing. Distinguished as both bioequivalent and therapeutically tantamount to Takeda Pharmaceuticals USA Inc’s reference listed drug FIRAZYR (Icatibant injection), this milestone holds considerable significance. The company announced the scheduled launch of this product in September 2023. Drawing attention to its market potential, Aurobindo Pharma indicated that the approved offering corresponds to a market size valued at approximately USD 137 million, as per IQVIA data encompassing the 12 months concluding in June 2023.

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