Drug Approval | December 04, 2023
AstraZeneca Pharma India receives permission from CDSCO to import new drug
The receipt of this permission paves way for the launch of BREZTRI AEROSPHERE in India
The receipt of this permission paves way for the launch of BREZTRI AEROSPHERE in India
Tremelimumab in combination with Durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC)
A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalization for heart failure in adults with CKD
The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals
Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)
With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction
The approval of this important test marks the 14th IVD to receive clearance by the CDSCO, and strengthens the company’s foundation for future growth
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