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Approvable Letter Issued for Ciclesonide, Treatment of Persistent Asthma
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