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Praxbind FDA Approval History

FDA Approved: Yes (First approved October 16, 2015)
Brand name: Praxbind
Generic name: idarucizumab
Dosage form: Injection
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Reversal Agent for Pradaxa

Praxbind (idarucizumab) is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa® (dabigatran) when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures; and in life-threatening or uncontrolled bleeding.

Development Timeline for Praxbind

Apr 17, 2018Approval FDA Provides Full Approval to Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa
Oct 16, 2015Approval FDA Approves Praxbind (idarucizumab) as a Reversal Agent for the Anticoagulant Pradaxa
Apr 23, 2015FDA Grants Priority Review to Boehringer Ingelheim’s Biologics License Application for Idarucizumab
Mar  2, 2015Boehringer Ingelheim Submits BLA to FDA for Idarucizumab, Investigational Specific Reversal Agent for Pradaxa

Further information

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