BioSante Pharmaceuticals, Inc., Teva Pharmaceutical Industries Limited Surge as FDA OKs Testosterone Gel

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and BioSante Pharmaceutical Inc. (Nasdaq: BPAX) have obtained US Food and Drug Administration (FDA) clearance for Bio-T-Gel, a testosterone replacement therapy for men. Teva will market the product for men suffering from hypogonadism (low testosterone), which can cause erectile dysfunction, infertility, osteoporosis and muscle loss, according to the Mayo Clinic. The gel is delivered transdermally once a day. BioSante initially developed Bio-T-Gel and licensed it to Teva for late stage clinical development in 2004. Teva filed the New Drug Application with the FDA and was responsible for all regulatory and marketing activities. Teva paid BioSante $1.4 million when the agreement was signed and it will pay royalties on sales.