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Within only six months of the manufacturer’s submission of the application, FDA approved a new drug to treat two bone disorders: osteoporosis in postmenopausal women and Paget’s disease.
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Fosamax (alendronate) is the first bisphosphonate drug approved for osteoporosis, providing an alternative to estrogen and calcitonin, previously approved treatments. Fosamax was approved last Sept. 29. Other bisphosphonates were previously approved for Paget’s disease.
Osteoporosis is a condition of low bone mass and reduced bone strength that leads to fractures of the spine, wrist and hip. In Paget’s disease, normal bone is replaced with poor quality bone.
WHITE, HOUSE STATION, N.J. — The Food and Drug Administration has approved Merck & Co.’s Fosamax Plus D (alendronate sodium/ cholecalciferol), a single once-weekly tablet containing 70 mg of Fosamax (alendronate sodium) and 2,800 IU of vitamin [D.sub.3], representing seven days’ worth of 400 IU of vitamin D.
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