Reclast granted broadened indication

June 10, 2008

FDA gives once-yearly zoledronic acid injection expanded use.

The Food & Drug Administration has broadened the indication for zoledronic acid (Reclast, Novartis) to include the prevention of fractures in patients who’ve had a recent hip fracture. The decision was based on safety and efficacy data from the Recurrent Fracture Trial that showed an increase in bone mineral density and a 35% reduction in risk of new fractures in patients treated with the drug compared with placebo. According to the manufacturer, Reclast is given as a once-yearly 15-minute intravenous infusion and, when taken along with calcium and vitamin D supplements, helps to protect against fracture for a full year.

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