FDA approves BioSante’s Bio-T-Gel
The FDA has approved Bio-T-Gel for the treatment of male hypogonadism (low testosterone levels), according to BioSante Pharmaceuticals.
The testosterone gel was initially developed by BioSante and then licensed to Teva Pharmaceutical 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.
"We are pleased that Bio-T-Gel will provide another treatment option to men suffering from low testosterone levels," said Stephen M. Simes, BioSante's president and CEO. "We are confident that Teva has the commercialization and marketing expertise to implement a successful launch, and we look forward to Bio-T-Gel reaching the market."
This news comes just weeks after the FDA rejected two of BioSante’s critical late-stage female libido gels.