A Clearinghouse for Information about Blood Clots (DVT/)PE) and Clotting Disorders (thrombophilia) provided as a public service by the University of North Carolina Blood Research Center

Tag: FDA

  • NO FDA Approval Yet for Andexanet

    Stephan Moll, MD writes… The FDA did NOT approve Andexanet (brand names: AndexXa™ in the US, IndexXa™ in Europe) in a decision on August 18th, 2016.  Andexanet is the antidote in clinical development to reverse the anticoagulant effect of Eliquis® (rivaroxaban), Savaysa® (edoxaban), Xarelto® (rivaroxaban) and Lovenox® (enoxaparin).  The FDA is said to have requested more information from…

  • Apixaban (Eliquis) FDA-Approval for DVT and PE Treatment

    Stephan Moll, MD writes…  Apixaban (Eliquis®) was approved by the FDA this week (Aug 21, 2014) for the treatment of DVT and PE.  The approval covers (a) acute DVT/PE management and (b) prevention of recurrent DVT/PE.

  • Pradaxa (Dabigatran) FDA-Approved for DVT and PE

    Stephan Moll, MD writes…  Today the FDA approved Pradaxa (dabigatran) for the treatment of venous thromboembolism, based on the phase 3 RECOVER and RECOVER II trials.  The dose is 150 mg twice daily for patients with a GFR > 30 ml/min.  Due to the design of the RECOVER and RECOVER II trials, the drug is approved…

  • Moving Fast: 4th Big New Oral Anticoagulant (Edoxaban, Savaysa) Applies For FDA Approval

    Stephan Moll, MD writes… 2014 promises to be quite a year regarding the new oral anticoagulants. On Jan 8th, 2013 the company Daiichi applied for FDA approval for their drug edoxaban (Savaysa®) for 2 indications: (a)  DVT and PE (venous thromboembolism; VTE) treatment, and (b) non-valvular atrial fibrillation and the prevention of systemic arterial thromboembolism.…

  • FDA to Review Eliquis (Apixaban) for DVT and PE Treatment

    Stephan Moll, MD writes… On Dec 19th the FDA accepted the application by Bristol-Myers Squibb (BMS) and Pfizer for review of Eliquis (apixaban) for the treatment of DVT and PE. The press release of BMS is here.  The goal date for a decision by the FDA is August 25, 2014.

  • New Oral Anticoagulants for DVT and PE: Update on FDA Applications

    Stephan Moll, MD writes…   1.  Pradaxa (Dabigatran) Today, August 28th, 2013, it was announced that the FDA is reviewing the application by Boehringer-Ingelheim to get Pradaxa (dabigatran) approved for use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) – details here. At present, in the US, Pradaxa is only FDA-approved for…

  • Xarelto and DVT – Approved in Europe

    Xarelto (Rivaroxaban) was approved in Europe today (Dec 19th, 2011) for patients with acute DVT. This is good news

  • Another New Blood Thinner FDA Approved : Xarelto (Rivaroxaban)

    Today the FDA approved Xarelto (Rivaroxaban) for irregular heart beat (= atrial fibrillation = a. fib).  The approved dose is 20 mg once daily.  The link to the FDA press release is here.  The Xarelto prescribing information can be found here. Xarelto for Blood Clots in the Veins (DVT and PE)