Pharma Business Week
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Pharma Business Week
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Biotechnology
FDA requests additional data on PULMINIQ
August 15th, 2005
Chiron Corp. (CHIR) announced that the company has received an action letter from the U.S. Food and Drug Administration (FDA) stating that the company's new drug application (NDA) for PULMINIQ (cyclosporine, USP) inhalation solution is "approvable" but that an additional preapproval study is required to confirm the efficacy of the drug. In the NDA for PULMINIQ, Chiron is seeking an indication to increase survival and prevent chronic rejection in patients receiving allogeneic lung transplants, in combination with standard immunosuppressive therapy. Chiron is evaluating possible next steps for PULMINIQ. "Chiron in-licensed PULMINIQ...
Source: Pharma Business Week (2005-08-15)
|
