FDA Committee Backs New Drug for Osteoporosis
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WASHINGTON — A slow-release sodium fluoride compound, supplemented with calcium, was recommended for approval as a new drug for osteoporosis by a Food and Drug Administration advisory committee on Friday.
The recommendation by the FDA endocrinological and metabolic drugs advisory committee is not binding on the agency, but such recommendations generally are followed.
If approved, the drug would be marketed by Mission Pharmacal, a manufacturer based in San Antonio. The company said the drug will cost less than $1 a day.
Studies showed that the combination of compounds builds new bone and prevents spinal fractures in post-menopausal women with osteoporosis.
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