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Approvable Letter Issued for Ciclesonide, Treatment of Persistent Asthma

October 26, 2004 -- Aventis, part of the sanofi-aventis Group, and Altana announced today the receipt of an approvable letter from the U.S. Food and Drug Administration (FDA) for Alvesco® (ciclesonide) for the treatment of persistent asthma (regardless of severity) in adults, adolescents and children four years of age and older.

Aventis and Altana signed an agreement in 2001 to jointly develop and market Alvesco® in the United States.

An approvable letter outlines specific issues that must be resolved before the Agency will approve a product for marketing.

Aventis is already working closely with the FDA to address the clinical data requests outlined in the letter.

Source: sanofi-aventis Group and Altana

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