Antares Pharma, Inc. Receives First FDA Approval Of ATD(TM) Gel Platform
EWING, N.J.--(BUSINESS WIRE)--Antares Pharma, Inc. (Amex: AIS) announced the U.S. Food and Drug Administration (FDA) approved for marketing Elestrin™ (formerly Bio-E-Gel®) in the United States. Antares’ development partner, BioSante Pharmaceuticals (Amex: BPA) announced today that Bio-E-Gel will be marketed under the name Elestrin™ by Bradley Pharmaceuticals Inc. (NYSE: BDY) and is indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause. Elestrin is the first FDA approved product in Antares’ Advanced Transdermal Delivery (ATD™) gel platform. Two doses of Elestrin, 0.87 grams per day and 1.7 grams per day, were approved and there are no future post-approval clinical development commitments required by the FDA. Elestrin (0.87 grams per day) is the lowest dose of estradiol currently approved by the FDA for the treatment of moderate-to-severe vasomotor symptoms. Antares currently retains the sole marketing rights of the product for Europe and elsewhere