5. November 2009 01:07
InterMune, Inc. (Nasdaq: ITMN) today announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.
"IPF is a rapidly and uniformly fatal disease. Sadly, there are no medicines approved for the approximately 100,000 Americans who suffer from this terrible disease," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "InterMune has dedicated almost ten years to the development of new medicines for patients with IPF. We are very proud to have submitted the first NDA ever submitted to the FDA for a medicine to treat IPF patients."
SOURCE InterMune, Inc.
8f13c14b-bc16-4e4a-a5ba-d52bf5df0960|1|5.0
Posted in: Medical Condition News | Pharmaceutical News
Tags: Anti-Inflammatory, Biotechnology, Cough, Dyspnea, Fibrosis, Hepatitis C, Hepatology, Idiopathic Pulmonary Fibrosis, New Drug Application, Pirfenidone, Toxicology, Virus
News-Medical.Net provides this medical information service in accordance
with these
terms and conditions.
Please note that medical information found
on this website is designed to support, not to replace the relationship
between patient and physician/doctor and the medical advice they may provide.
Subscribe