FDA accepts regulatory application for Bio-T-Gel
LINCOLNSHIRE, Ill. — The Food and Drug Administration has accepted a regulatory approval application for a topical treatment for low testosterone made by Teva Pharmaceuticals and BioSante Pharmaceuticals, BioSante said Wednesday.
The two companies said the FDA had accepted their application for Bio-T-Gel and expected to complete its review by mid-November.
BioSante originally developed the gel and will receive milestone payments and royalties, and Teva will take responsibility for regulatory and marketing activities. The market for male testosterone products in the United States is more than $1.2 billion, according to BioSante.