Label Changes for:
Letairis (Ambrisentan) Tablets
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013
- Letairis was consistently shown to have teratogenic effects when administered to animals.