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Actelion Receives FDA Approval of Tracleer (bosentan) for Use in Pediatric Patients with Pulmonary Arterial Hypertension
Posted 14 Sep 2017 by Drugs.com
SOUTH SAN FRANCISCO, Calif, September 6, 2017 – Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that the U.S. Food and Drug Administration (FDA) has approved a new 32 mg tablet for oral suspension for Tracleer (bosentan) for use in pediatric patients aged three years and older with idiopathic or congenital pulmonary arterial hypertension (PAH), to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. With this approval, Tracleer becomes the first FDA-approved medicine for pediatric PAH patients in the United States. PAH is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected person. Tracleer is an orally active endothelin receptor antagonist (ERA) for the treatment of p ... Read more
Posted 16 Sep 2011 by Drugs.com
FRIDAY, Sept. 16 – Despite ongoing prevention efforts, a growing number of young children are being accidentally poisoned with medications, according to new research. The study, which was based on data reported to the American Association of Poison Control Centers between 2001 and 2008, found that medication poisoning among children aged 5 and under increased by 22 percent, although the number of children in the United States in this age group rose by only 8 percent during the study period. "The problem of pediatric poisoning in the U.S. is getting worse, not better," Dr. Randall Bond, of Cincinnati Children's Hospital Medical Center, said in a hospital news release. In conducting the study, which is scheduled for publication in the Journal of Pediatrics, the researchers reviewed information on over 544,000 children who landed in the emergency department due to medication poisoning ... Read more
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