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The company stated that it is reviewing the letter and will cooperate with the FDA to determine the next step in its application.
The current application for lasofoxifene was submitted by Pfizer on 18 December 2007. An FDA scientific advisory panel voted 9 to 3 that there is a population of post-menopausal women with osteoporosis for whom the benefits of lasofoxifene would likely outweigh the risks. The FDA is not required to follow the panel's advice.
Lasofoxifene is a selective oestrogen receptor modulator (SERM), currently under review for the treatment of osteoporosis in post-menopausal women with an increased risk of fracture.
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