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Antares Pharma, Inc.

Antares announces U.S. FDA acceptance of NDA for transdermal estradiol gel

Published in Health Risk Factor Week, May 16th, 2006

Antares Pharma, Inc., (AIS) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review its licensee's (BioSante Pharmaceuticals, Inc.), New Drug Application (NDA) for transdermal estradiol gel (Bio-E-Gel).

The NDA includes data from a phase III clinical trial as well as data from a sunscreen study, a pharmacokinetic study and a transfer study.

Bio-E-Gel is a low dose estradiol product candidate based on Antares' proprietary Advanced Transdermal Delivery (ATD) gel system and, if approved, will be used to treat moderate-to-severe hot flashes in menopausal women. Antares' ATD system is designed to deliver hormones and...

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