In May 2008, Gilead announced the initiation of ATHENA-1, a Phase IV, randomized, double-blind, placebo-controlled study evaluating Letairis (ambrisentan 5mg and 10mg tablets) in patients with PAH demonstrating a sub-optimal response to sildenafil monotherapy.
INTRODUCTION. Pulmonary hypertension is a chronic disorder caused by changes in the pulmonary vasculature that results in an increase in blood pressure in the lungs. 1 Several complex mechanisms are proposed to play roles in the pathophysiology of this condition, including the up-regulation of endothelin production and the down-regulation of nitric oxide and prostacyclin.
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4/1/2018 · The majority of patients were female with PAH associated with connective tissue disease and their ERA was changed in the hope of improving efficacy. The process was well tolerated with no adverse events associated with the process. Seventeen patients died during the study (macitentan, n = 5; ambrisentan, n = 12).
7r01fd005406-02phase i study of viralym-a for the treatment of adenovirus disease - ind16258 (11/13/2014) kakarla, sunitha viracyte, llc 2017-9247 nda 018450 2017-9248
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6/19/2012 · Responsive Documents - CREW: FDA: Regarding FOIA Logs: 6/19/2012 - CREWLog Response - Free ebook download as PDF File (.pdf), Text File (.txt) or read book online for free. On June 7, 2012, Citizens for Responsibility and Ethics in Washington (CREW) sent two Freedom of Information Act (FOIA) requests to the Food and Drug Administration (FDA).