www.fdanews.com/articles/75939-expanded-label-for-ventavis-includes-device
EXPANDED LABEL FOR VENTAVIS INCLUDES DEVICE
August 31, 2005
CoTherix has received approval from the FDA to modify the Ventavis Inhalation Solution label to include the use of a Respironics device for delivery purposes.
Respironics' portable, hand-held I-neb AAD device for the delivery of Ventavis is currently pending receipt of FDA 510(k) regulatory clearance. Ventavis (iloprost) Inhalation Solution is approved for the treatment of pulmonary arterial hypertension, a highly debilitating and potentially fatal disease characterized by high blood pressure in the pulmonary arteries of the lungs, in patients with NYHA Class III or IV symptoms.
The company expects to begin the initial roll out of the I-neb to patients by the end of the year.