FDA grants Orphan Drug status to Aradigm's liposomal ciprofloxacin for cystic fibrosis

By Lisa Kerner

Erie, Pa., May 9 - The Food and Drug Administration has granted Orphan Drug designation to Aradigm Corp.'s proprietary liposomal formulation of ciprofloxacin for the management of cystic fibrosis.

The company's liposomal ciprofloxacin, an aerosolized formulation of the anti-infective drug, was designed to increase the amount of time the drug stays in the lung to treat infections.

As a designated orphan drug, liposomal ciprofloxacin is eligible for tax credits based upon its clinical development costs, as well as assistance from the FDA in guiding the drug through the regulatory approval process.

Orphan drug designation also provides Aradigm with seven years of market exclusivity.

Cystic fibrosis is a genetic disease affecting approximately 60,000 children and adults worldwide. A defective gene causes production of excess mucus that clogs the lungs, leaving patients vulnerable to life-threatening lung infections, according to a company news release.

Aradigm is a Hayward, Calif., biopharmaceuticals company specializing in drug delivery solutions.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.