FDA accepts Antares' Bio-E-Gel NDA
USA-based drugmaker Antares Pharma says that the Food and Drug Administration has accepted its filing of a New Drug Application regarding its transdermal estradiol gel, Bio-E-Gel. If approved, the product will be used in the treatment of moderate-to-severe hot flashes in menopausal women, via the delivery of hormones and other active ingredients across the skin for absorption into the bloodstream.
The NDA, which Antares submitted in partnership with fellow US firm BioSante, is comprised of data from a Phase III clinical evaluation of the product, as well as a sunscreen study and full pharmacokinetic information.
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