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FDA approves Estrasorb.
2003 NOV 6 - (NewsRx.com & NewsRx.net) -- Novavax, Inc., (NVAX) and King Pharmaceuticals, Inc., (KG) announced that the U.S. Food and Drug Administration (FDA) has approved Estrasorb (estradiol topical emulsion), the first prescription topical emulsion for estrogen therapy.
Estrasorb, which utilizes a topical formulation developed by Novavax, is approved for short-term use to reduce moderate-to-severe vasomotor symptoms - commonly known as "hot flashes" - in menopausal women.
"The approval of Estrasorb marks the culmination of over 9 years of work on our proprietary micellar nanoparticle (MNP) drug delivery platform," commented Nelson M. Sims, president and CEO of Novavax.
He continued: "As a result, we have the opportunity to create a unique position within the $1.6 billion domestic estrogen therapy market. We are also optimistic about the potential of our proprietary MNP ...
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NOVAVAX, INC. and KING PHARMACEUTICALS...ESTRASORB(TM) (estradiol topical emulsion), the first prescription topical emulsion for estrogen therapy. ESTRASORB...topical formulation developed by Novavax, is approved for short-term...
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...Reported at NAMS Meeting. NOVAVAX, INC. announced that...Estrasorb (estradiol topical emulsion), compared with those...CEO (Interim) of Novavax, Inc. "We are tremendously...nanoparticles, the topical emulsion drug delivery system currently employed by Novavax, Inc. for ...
- Results of Phase III Clinical Trial Reveal Estrasorb(TM) (estradiol topical...
- Press release article from: PR Newswire October 4, 2002 700+ words
...Estrasorb (estradiol topical emulsion), compared with those...CEO (Interim) of Novavax, Inc. "We are tremendously...nanoparticles, the topical emulsion drug delivery system currently employed by Novavax, Inc. for estradiol...
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- Press release article from: PR Newswire March 22, 2002 700+ words
...using Estrasorb (estradiol topical emulsion) experienced an eighty...therapies. Estrasorb uses Novavax's micellar nanoparticle...5%) or redness (1%). Novavax, Inc., is a specialty biopharmaceutical...and infectious diseases. Novavax has several product candidates...
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- News wire article from: Asia Africa Intelligence Wire October 4, 2002 700+ words
...5 to 3 times more patients using Estrasorb (estradiol topical emulsion), compared with those using placebo, achieved a complete...II/III, dose-ranging, clinical study was completed. Novavax Inc, is a speciality biopharmaceutical company engaged in...
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- Magazine article from: Internal Medicine Alert Elliott, William T. Chan, James January 15, 2004 700+ words
...estrogen emulsion provides another option for estrogen therapy. Novavax Inc markets this topical formulation as Estrasorb. Indications...4-7) References (1.) Estrasorb Product Information. Novavax Inc. October 2003. (2.) WHI Investigators. JAMA. 2002...
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...from 1998-2002. Novavax grew 2,103% during this period. Novavax's President...first prescription topical emulsion for estrogen therapy...recently approved topical emulsion for estrogen therapy, Novavax has several product...
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- Press release article from: PR Newswire June 21, 2004 700+ words
...Accessed Via Live Webcast - Novavax, Inc. today announced that...Sims, President and CEO of Novavax, is scheduled to present...launch of its proprietary topical emulsion for estrogen therapy, ESTRASORB...Drake Hotel in Chicago, IL. Novavax's presentation is scheduled...
Source: HighBeam Research, FDA approves Estrasorb.