| Document Date: 2009-06-10 14:41:45
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Company Gilead Sciences Inc. / / Event FDA Phase / / IndustryTerm food / / MedicalCondition abdominal pain / POTENTIAL LIVER INJURY / hypertension / flushing / liver dysfunction / Nasopharyngitis / Dyspnea / only nasal congestion / pulmonary arterial hypertension / Carcinogenesis / serious hepatic injury / nausea / nasal congestion / itching / pulmonary hypertension / fever / unexplained hepatic cirrhosis / vomiting / unusual lethargy / fatigue / pulmonary / heart failure / sinusitis / dose-dependent liver injury / liver injury / constipation / serious liver injury / birth defects / / MedicalTreatment oral contraceptives / contraception / vasectomy / / Organization World Health Organization / DOSAGE AND ADMINISTRATION / FDA / / / Position counsel / physician / Major / / Product itraconazole / Cyclosporine / ketoconazole / clarithromycin / omeprazole / rifampin / LETAIRIS / CYP3A / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ® LETAIRIS tablets safely and effectively. See full prescribing information for LETAIRIS. LETAIRIS (ambrisentan) ta