BioSante Pharmaceuticals Announces Teva New Drug Application for Bio-T-Gel

BioSante Pharmaceuticals, Inc. BPAX today announced that a New Drug Application has been accepted for filing by the U.S. Food and Drug Administration following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries Ltd. TEVA. The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA. 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. The current U.S. market for male testosterone products is over $1.2 billion.