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A new
lotion developed for use by menopausal women to help control
hot flashes has been stalled in getting approval by the U.S.
Food and Drug Administration (FDA).
Novavax
Inc. has withdrawn its application for FDA approval for Estrasorb,
an estrogen-replacement lotion.
The application
withdrawal came after the FDA requested additional information
about the company's chemistry manufacturing and controls.
Novavax
claims the FDA did not raise questions about Estrasorb's safety
or effectiveness and believes the therapy will eventually
get FDA approval and their questions have been addressed.
Source:
Medical Week staff,
week of April 28, 2002
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