By: IPP Bureau
Last updated : January 22, 2024 11:10 am
The receipt of this permission paves way for the launch of Andexanet alfa powder for solution for infusion 200 mg (Andexxa) in India
AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from Central Drugs Standard Control Organisation for Andexanet alfa powder for solution for infusion 200 mg (Andexxa).
Through this approval, Andexanet alfa is indicated for patients treated with FXa inhibitors (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
The receipt of this permission paves way for the launch of Andexanet alfa powder for solution for infusion 200 mg (Andexxa) in India for the specified indication, subject to the receipt of related statutory approvals, if any.