Praxbind dose5/13/2023 In the studies, the reversal effects of PRAXBIND were evident immediately, within minutes after administration of 5 grams of PRAXBIND. The application included data from healthy volunteers as well as results from an interim analysis of the RE-VERSE AD™ trial ( NCT02104947). PRAXBIND was approved under an Accelerated Approval Pathway. The FDA granted PRAXBIND Breakthrough Therapy Designation and the application received Priority Review. Continued approval for the indication may be contingent upon the results of an ongoing cohort case series study. This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. Food and Drug Administration (FDA) approved PRAXBIND in October 2015 for patients treated with PRADAXA, when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. The zip code locator tool and additional information about stocking PRAXBIND are available at or by calling 1‑800‑542‑6257 (Opt 1). Orders can generally be filled or restocked within 24 hours. hospital pharmacy distributors ASD, Cardinal Health, MPB, HD Smith and Morris Dickson. PRAXBIND is manufactured and marketed by Boehringer Ingelheim Pharmaceuticals and is distributed by U.S. Physicians and patients can now have the reassurance of knowing PRAXBIND is available at more than 2,200 healthcare institutions." "In the rare event that a patient may need PRAXBIND, it is critical that it is readily available. "Boehringer Ingelheim is proud to have been able to make PRAXBIND, the first specific reversal agent for a NOAC, available, and that we have been able to distribute it broadly nationwide," said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. The company recently launched a new locator tool on that helps healthcare providers and PRADAXA patients to quickly identify institutions that have stocked PRAXBIND by entering a zip code. RIDGEFIELD, Conn., Ma/PRNewswire/ - Today, Boehringer Ingelheim announced that Praxbind® (idarucizumab), a specific reversal agent for Pradaxa® (dabigatran etexilate mesylate), a novel oral anticoagulant (NOAC), is now stocked in more than 2,200 hospitals in all fifty states.
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