- FDA re-examining risk profile of FDA-approved testosterone products
- Senate passes Drug Quality and Security Act
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- FDA advisory panel to consider OTC status of NSAIDs
- 21 health industry groups address FDA on proposed changes to generic drug label rules
CHADDS FORD, Pa. — The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.
The drug maker announced on Dec. 29 the approval of Fortesta (testosterone) gel, a treatment for men with low testosterone, which affects nearly 14 million men in the United States.
Endo said it planned to introduce Fortesta in the United States early this year.