www.fdanews.com/articles/69034-aerogen-combination-product-receives-fast-track-designation
Aerogen Combination Product Receives Fast-Track Designation
February 22, 2005
The FDA has given fast-track designation to Aerogen's Amikacin Pulmonary Delivery System for Ventilator-Associated Pneumonia (VAP).
The delivery system is a combination product that uses the company's Aerosol Generator technology to deliver high efficiency aerosol to patients on mechanical ventilators.
According to the company, the FDA granted its product fast-track designation because of the high mortality rate associated with VAP and because Aerogen's product "offers the possibility of reducing systemic toxicity."