Women's Health Weekly
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Hormone Replacement Therapy
Topical Estrogen Replacement Therapy Accepted For Review
October 4th, 2001
King Pharmaceuticals, Inc. reported September 5, 2001, that the U.S. Food and Drug Administration has accepted for review the New Drug Application (NDA) for Estrasorb (17-beta-estradiol) cream, a topical estrogen replacement therapy licensed to King by Novavax, Inc. Estrasorb employs Novavax's proprietary micellar nanoparticle (MNP) technology, which is designed to deliver 17-beta-estradiol, a naturally occurring hormone, through the skin when applied topically in the form of a lotion. The NDA contains results from Novavax's pivotal Phase III study, a randomized, double-blind, placebo controlled trial that enrolled a total of 200 women either on...
Source: Women's Health Weekly (2001-10-04)
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