Gilead's Aztreonam For Inhalation Solution To Be Reviewed By FDA Anti-Infective Drugs Advisory Committee On December 10, 2009

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 28 Oct 2009 - 0:00 PDT

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Gilead Sciences, Inc. (Nasdaq:GILD) announced that aztreonam for inhalation solution, an investigational product for the treatment of infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF), is scheduled to be reviewed by the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) on December 10, 2009.

In September 2009, the product was granted conditional marketing approval in Canada and Europe under the trade name Cayston® (aztreonam lysine 75 mg powder and solvent for nebuliser solution). Applications for marketing approval of Cayston are also pending in Australia, Switzerland and Turkey.

About Aztreonam for Inhalation Solution

Aztreonam for inhalation solution is an antibiotic candidate for people with cystic fibrosis who have P. aeruginosa. Aztreonam has potent in vitro activity against Gram-negative bacteria such as P. aeruginosa. Aztreonam formulated with arginine is an FDA-approved agent for intravenous administration for treating various infections. Aztreonam formulated with lysine is a proprietary formulation of aztreonam developed specifically for inhalation. It has been designated with orphan drug status in the United States and Europe.

Source
Gilead Sciences