Regulatory Affairs

BioSante wins FDA nod for testosterone gel

PBR Staff Writer Published 16 February 2012

BioSante Pharmaceuticals has won FDA approval for Bio-T-Gel, a testosterone gel for the treatment of male hypogonadism or low testosterone levels.

The product was initially developed by BioSante and latter licensed to Teva for late stage clinical development, regulatory and marketing activities.

BioSante is expected to receive royalties and certain milestone payments upon commercialization of Bio-T-Gel.

BioSante president and CEO Stephen Simes said that Bio-T-Gel will provide another treatment option to men suffering from low testosterone levels.

"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," Simes added.