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Pfizer receives request from FDA for more information on application for lasofoxifene

Posted on: Mon, 19 Jan 2009 10:24:00 EST

Symbols: PFE

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Jan 19, 2009 (M2 EQUITYBITES via COMTEX) --
PFE | Quote | Chart | News | PowerRating -- Pfizer Inc (NYSE:PFE), a pharmaceutical company, announced on 16
January that it has received a complete response letter from the US
Food and Drug Administration (FDA) requesting additional information of
the company's application for lasofoxifene.

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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