Asthma

New drug application submitted to FDA for Alvesco

Published in Medical Letter on the CDC and FDA, February 1st, 2004

Aventis and Altana announced that a new drug application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for Alvesco (ciclesonide).

The companies are seeking marketing approval of Alvesco for the treatment of persistent asthma (regardless of severity) in adults, adolescents and children 4 years of age and older. Aventis and Altana signed an agreement in 2001 to jointly develop and market Alvesco in the United States.

Alvesco is a new generation inhaled corticosteroid with novel release and distribution properties. Inhaled corticosteroids are considered to be the foundation of asthma treatment, and they work by reducing...

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Source: Medical Letter on the CDC and FDA (2004-02-01)

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