BioSante Pharmaceuticals has. announced that a New Drug Application has been accepted for filing by the FDA following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries. Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Bio-T-Gel was developed initially by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante will receive certain milestone payments and royalties upon commercialization.
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