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CDSCO Drug Approvals | India | Pharma | Health | Drug Approvals | 2024 | iPharmaCenter


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22 Jan 2024

AstraZeneca Granted CDSCO Authorization for Andexanet Alfa: Revolutionary Antidote for Severe Bleeding Tied to FXa Inhibitors

AstraZeneca Granted CDSCO Authorization for Andexanet Alfa: Antidote for Severe Bleeding Tied to FXa Inhibitors

AstraZeneca announced today that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) in India to import and market Andexanet Alfa. This innovative solution is designed to address life-threatening or persistent bleeding associated with the use of Factor Xa (FXa) inhibitors.


FXa inhibitors are used to prevent and manage thrombotic events like deep vein thrombosis and pulmonary embolism, as well as in patients at a high risk of stroke due to atrial fibrillation. While these medications effectively prevent unwanted clot formation, they also elevate the risk of severe bleeding, which can be life-threatening.


Andexanet Alfa has demonstrated both efficacy and safety in clinical trials involving healthy subjects and patients with severe life-threatening bleeding. This antidote is designed to reverse the effects of anticoagulant medications in emergency situations.


It is well-tolerated and allows for the prompt resumption of anticoagulation following a bleeding event. The therapy is administered through an intravenous (IV) bolus over a duration of 15–30 minutes, followed by a 2-hour infusion.


AstraZeneca stated that it was committed to advancing medical solutions that address critical healthcare needs, ensuring that healthcare providers in India have access to innovative treatments that can make a meaningful difference in patient outcomes.

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