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The FDA has broadened the US indication for Novartis' Reclast (zoledronic acid) once-yearly injection to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture. The FDA decision is based on safety and efficacy data from the “Recurrent Fracture Trial,” published in The New England Journal of Medicine. Trial results showed a 35% reduction in the risk of new clinical fractures in patients treated with Reclast, Novartis said.
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