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BioSante Pharma Announces FDA Approval For Bio-T-Gel - Quick Facts

BioSante Pharmaceuticals, Inc. (BPAX) announced that the U.S. Food and Drug Administration or FDA has approved Bio-T-Gel, which is licensed by BioSante to Teva Pharmaceuticals USA, Inc.

Giving a brief description of Bio-T-Gel, the company said it is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Male hypogonadism is generally characterized by impotence, a lack of sex drive, muscle weakness and osteoporosis.

BioSante stated that Bio-T-Gel was initially developed by the company, 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 royalties and may receive certain milestone payments upon commercialization of Bio-T-Gel.

The current U.S. market for male testosterone products is estimated at over $1.6 billion.

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