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FDA approves Tracleer for pediatric PAH

September 6, 2017 11:20 PM UTC

FDA approved a 32 mg tablet of Tracleer bosentan to treat pulmonary arterial hypertension in children ages three 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...