FDA approves new indication for Novartis osteoporosis drug

BASEL, Switzerland Novartis announced Thursday that the Food and Drug Administration had approved a new indication for the injected postmenopausal osteoporosis drug Reclast, known generically as zoledronic acid.

The approval follows a study published in The New England Journal of Medicine showing that Reclast can safely and effectively reduce the risk of clinical fractures in osteoporosis patients who have already had low-trauma hip fractures by 35 percent.

The FDA already approved Reclast for treating osteoporosis. It is the only drug that has been approved for preventing fractures that occur after hip fractures.

Reclast had sales of $41 million in 2007, according to Novartis financial reports.