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A new drug application (NDA) for the approval of apixaban was submitted to the US Food and Drug Administration (FDA) by Bristol-Myers Squibb (BMS) and Pfizer jointly after the conclusion of the ARISTOTLE clinical trial in 2011. [29] [15] Apixaban was approved for the prevention of stroke in people with atrial fibrillation in December 2012.
Side effects may include bleeding, most commonly from the nose, gastrointestinal tract (GI) or genitourinary system. [2] Compared to the risk of bleeding with warfarin use, direct factor Xa inhibitors have a higher risk of GI bleeding, but lower risk of bleeding in the brain. [2]
Botox and Botox Cosmetic were given the generic name of onabotulinumtoxinA, Myobloc as rimabotulinumtoxinB, and Dysport retained its generic name of abobotulinumtoxinA. [84] [80] In conjunction with this, the FDA issued a communication to health care professionals reiterating the new drug names and the approved uses for each. [85]
U.S. FDA Approves ELIQUIS ® (apixaban) to Reduce the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation ELIQUIS Demonstrated Superior Risk Reductions Versus ...
Bristol-Myers Squibb and Pfizer Announce U.S. FDA Approval of ELIQUIS ® (apixaban) PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYS: BMY) and Pfizer Inc. (NYS: PFE ...
Botox may be best known for its ability to combat crow's feet and other facial wrinkles, but it also serves an important role in the medical community. Since it was first approved for two eye ...
ADDING MULTIMEDIA: FDA Approves BOTOX ® Cosmetic (onabotulinumtoxinA) for Temporary Improvement of Moderate to Severe Lateral Canthal Lines (Crow's Feet Lines) in Adults Newest Indication for ...
Rivaroxaban (Xarelto) was the first approved FXa inhibitor to become commercially available in Europe and Canada in 2008. [1] The second one was apixaban (Eliquis), approved in Europe in 2011 [2] and in the United States in 2012. [3] The third one edoxaban (Lixiana, Savaysa) was approved in Japan in 2011 and in Europe and the US in 2015. [4]