BioCentury
ARTICLE | Clinical News

FDA approves Tracleer for pediatric PAH

September 8, 2017 8:41 PM UTC

FDA approved a 32 mg tablet of Tracleer bosentan to treat pulmonary arterial hypertension in children ages 3 and older. Johnson & Johnson (NYSE:JNJ) gained Tracleer in its June acquisition of Actelion Ltd.

Actelion said Tracleer is the first FDA-approved drug for pediatric PAH, and that the pediatric dose will be available in the U.S. in 4Q17. The dual endothelin A and B receptor antagonist is already available in 62.5 and 125 mg doses for adults with PAH. The pediatric dose was approved in the EU in 2009 (see BioCentury, July 13, 2009)...