Letairis - 2007 FDA approvals

Drug: Letairis (ambrisentan)
Indication: Pulmonary arterial hypertension
Company: Gilead Sciences
Approval Date: June 15, 2007

Scoop: Letairis is a once-daily endothelin receptor antagonist (ERA). The approval marked Gilead's entry into the lucrative cardiovascular space. Gilead is taking a conservative approach in marketing Letairis due to the potential for serious side effects. The company will only allow someone to gain a prescription for the drug after they have taken an education course into risk factors such as liver damage and birth defects.

More news:
Gilead shares surge on Letairis approval. Report
Gilead's NDA for ambrisentan damages Encysive shares. Report