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PARI Pharma's Altera Delivers Gilead's Cayston, Approved by the U.S. FDA for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients With Pseudomonas aeruginosa
Date:2/23/2010

MONTEREY, Calif., Feb. 23 /PRNewswire/ -- Altera, which uses eFlow Technology, was cleared to market today by the FDA as the first drug-specific nebulizer for use in the treatment of patients with cystic fibrosis and has been specifically developed to deliver Gilead Sciences' Cayston (aztreonam for inhalation solution) 75 mg.  Cayston is a new inhaled antibiotic that received marketing approval from the U.S. Food and Drug Administration (FDA) yesterday as a treatment to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa). The safety and efficacy of Cayston have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second (FEV(1)) of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

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