- Senate passes Drug Quality and Security Act
- FDA re-examining risk profile of FDA-approved testosterone products
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- 21 health industry groups address FDA on proposed changes to generic drug label rules
- Teva launches generic drug for cystic fibrosis patients
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.