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FDA approves new FOSAMAX PLUS to reduce the risk of both hip and spine fractures.

Merck & Co., Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved FOSAMAX PLUS D (alendronate sodium/cholecalciferol), a single once-weekly tablet containing 70 mg FOSAMAX[R] (alendronate sodium) and 2800 IU vitamin D3, representing seven days worth of 400 IU of vitamin D. (The recommended intake of vitamin D is 400-800 IU daily). FOSAMAX has been demonstrated to reduce the risk of both hip and spine fractures in postmenopausal women with osteoporosis and is now the only bisphosphonate with the added benefit of a weekly dose of vitamin D.

"The approval of FOSAMAX PLUS D is important news for women diagnosed with osteoporosis," said Robert Heaney, M.D., professor of medicine, Creighton University, Omaha, Nebraska. "This product will provide physicians with an important new option providing the well documented clinical benefit of FOSAMAX with the added advantage that those patients taking it are receiving a weekly dose of vitamin D. Having a product like FOSAMAX PLUS D available to help physicians better manage vitamin D nutrition in their patients should be welcomed news for the estimated 10 million Americans who have osteoporosis and the physicians who treat them."

Maintaining adequate levels of vitamin D is necessary for the development of strong bones because it helps increase the intestinal absorption of calcium. Vitamin D insufficiency is associated with reduced calcium absorption, bone loss and increased risk of fracture. Patients at increased risk for vitamin D insufficiency (e.g., those who are nursing-home bound, chronically ill, over the age of 70 years) and with gastrointestinal malabsorption syndromes should receive vitamin D supplementation in addition to that provided in FOSAMAX PLUS D.
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Title Annotation:Industry News
Publication:Pharmaceutical Processing
Date:May 1, 2005
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