Αποτελέσματα Αναζήτησης
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Division of Gastrointestinal and Coagulation Drug Products has requested that AstraZeneca participate in a Cardiovascular and Renal Drugs Advisory Committee review of this application. This briefing document has been prepared to support that review.
Ximelagatran is the first oral treatment in a new World Health Organization class of direct thrombin inhibitors and is the first new oral anticoagulant since the introduction of warfarin almost 60 years ago ( ). It was submitted to the Food and Drug Administration (FDA) for approval in December 2003 ( ).
25 Οκτ 2005 · Ximelagatran has been evaluated in the areas of venous thromboembolism management, particularly after orthopedic surgery, and stroke prevention in patients with atrial fibrillation. Overall, ximelagatran's efficacy appears comparable to other anticoagulants in these clinical settings.
6 Οκτ 2004 · AstraZeneca’s Exanta “Not Approvable” At FDA. 08 Oct 2004. • By Lee Kalowski. Review decision comes two weeks ahead of the anticoagulant’s user fee date and follows CEO McKillop’s comments to investors that “we can’t be optimistic about the outcome of discussions with the FDA.” Ask The Analyst. Download. Bookmark. 10 Sep 2004. 06 Oct 2004.
Ximelagatran (Exanta), the first available oral direct thrombin inhibitor, and its active form, melagatran, have been evaluated in the prevention of venous thromboembolism (VTE) in patients undergoing hip or knee replacement.
29 Αυγ 2012 · On 10 September, the US FDA Cardiovascular and Renal Drugs Advisory Committee overwhelming voted against the approval of AstraZeneca’s Exanta™ (ximelagatran) — a decision that caught many in the industry off-guard.
Ximelagatran (Exanta, AstraZeneca) is a novel oral direct thrombin inhibitor that inhibits the final step in the coagulation process - namely, the conversion of fibrinogen to insoluble fibrin by thrombin. Recently completed large clinical trials have evaluated the efficacy and safety of ximelagatran …
