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J&J gets regulatory nod for lung drug Tracleer in China

Johnson & Johnson unit Actelion Pharmaceuticals Ltd. said its drug Tracleer received marketing approval from China's National Medical Products Administration to treat children with pulmonary hypertension.

J&J said the approval makes Tracleer, or bosentan, the first approved drug for children with the disease in China.

Pulmonary hypertension is a rare disease categorized by high blood pressure that affects the arteries in the lungs and heart.

Tracleer was also included in a second list of 30 foreign drugs classified as "urgently needed" by Chinese regulators in March. Inclusion in the list enables companies to to receive regulatory approval for importation of the drugs in about six months, compared to the standard process that can sometimes take years.