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Novavax Estrasorb review extension

Executive Summary

FDA extends Novavax Estrasorb July 12 user fee date by three months to Oct. 10. Company expects extension of review period will not delay its planned launch for the first quarter of 2004. Novavax voluntarily withdrew the estrogen replacement cream NDA in April 2002 due to chemistry, manufacturing and controls concerns (1"The Pink Sheet" April 29, 2002, In Brief)...

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