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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]
In July 2016, the US Food and Drug Administration (FDA) approved abobotulinumtoxinA (Dysport) for injection for the treatment of lower-limb spasticity in pediatric patients two years of age and older. [53] [54] AbobotulinumtoxinA is the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. [55]
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 ...
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 ...
Medication that have label indications mean that they were approved by the FDA. This means that they are clinically significant for the indication and manufacturers are allowed to market their drug for the indication. [2] A drug can have more than one FDA labeled indication, which means that it can be used for multiple medical conditions. [5]
Dr. Melissa Doft explains why the neuromodulator is worth considering as part of an aesthetic treatment plan.