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J&J announces results of phase-3 trial of rivaroxaban
CHICAGO An investigational drug made by Johnson & Johnson is more effective in reducing the risk of stroke in patients with a trial fibrillation than a widely available generic, the drug maker said Monday.
J&J announced results of the phase-3 “Rocket-AF” trial of rivaroxaban, saying results showed that a once-daily dose of the drug worked better than warfarin, the most commonly used drug for preventing stroke in AF patients. Rivaroxaban also was comparable in terms of safety.
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GPhA responds to possibility of more stringent FDA regulations
NEW YORK — A ghost from 2008 soon could come back to haunt 2010.
According to published reports, the Food and Drug Administration may be considering adopting tougher standards for certain classes of generic drugs if it determines that some are not equivalent to their branded counterparts.