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FDA Law Weekly

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Hip Replacements



Study data from University of the Pacific update understanding of hip replacements



October 1st, 2009

According to a study from the United States, "Rivaroxaban is a highly potent direct factor Xa inhibitor with competitive and reversible activity that is pending FDA approval for the indication of venous thromboembolism (VTE) prophylaxis in patients undergoing total knee replacement (TKR) or total hip replacement (THR) surgery. Unlike the currently prescribed VTE prophylactic agents, which require subcutaneous (SC) administration or exhibit an undesirable drug interaction/monitoring profile, this agent offers the convenience of once-daily oral dosing, without the inconvenience of laboratory monitoring."

"In multiple phase 3 trials, rivaroxaban has demonstrated superior...


Source: FDA Law Weekly (2009-10-01)

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