| Document Date: 2009-08-13 18:52:31
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Company Gilead Sciences Inc. / Sildenafil Gilead Sciences Inc. / / IndustryTerm food / / MedicalCondition abdominal pain / POTENTIAL LIVER INJURY / marked oligospermia / 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 / angioedema / hypersensitivity / sinusitis / dose-dependent liver injury / liver injury / constipation / serious liver injury / rash / birth defects / anemia / clinically significant anemia / / MedicalTreatment oral contraceptives / contraception / vasectomy / / Organization World Health Organization / DOSAGE AND ADMINISTRATION / FDA / / / Position counsel / physician / Major / / Product FDA-Approved Medication / Cyclosporine / digoxin / ketoconazole / Ortho-Novum / omeprazole / rifampin / LETAIRIS / / 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