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Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
Date:8/19/2007

with Reclast therapy. In the Pivotal Fracture Trial an increased number of cases of serious atrial fibrillation were observed in women given Reclast compared to those on placebo (1.3% vs. 0.4% respectively)(2). The timing of these events suggest that they were not related to the acute infusion. This finding has not been observed in other zoledronic acid clinical studies and in post-marketing experience from more than 1.5 million patients treated with Zometa.

All patients with Paget's disease should receive 1500 mg of calcium in divided doses and 800 IU of vitamin D daily, particularly in the two weeks following Reclast administration. It is recommended that patients with postmenopausal osteoporosis take calcium and vitamin D supplements, if dietary intake is not sufficient.

For more information about Reclast, visit http://www.reclast.com or call 866-RECLAST (866-732-5278).

Disclaimer

The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "potential", "anticipated", "generally follows", "expected", "hope", "will", or similar expressions, or by express or implied discussions regarding potential future regulatory approvals of Reclast/Aclasta, or potential future sales of Reclast/Aclasta. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Reclast/Aclasta will be approved for sale, or for any additional indications or labeling in any market, or that Reclast/Aclasta will reach any particular level of sales. In particular, management's expectations regarding Reclast/Aclasta could be affected by, among other things, unexpected reg
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SOURCE Novartis Pharmaceuticals Corporation

Copyright©2007 PR Newswire.

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