Aventis Receives Approvable Letter from U.S. Food and Drug Administration for Alvesco® (ciclesonide) for Treatment of Pe
Aventis Receives Approvable Letter from U.S. Food and Drug Administration for Alvesco® (ciclesonide) for Treatment of Persistent Asthma Paris, France and Bad Homburg, Germany, 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 Alvescoâ (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 Alvescoâ 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. About sanofi-aventis The sanofi-aventis Group is the world's 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY). About ALTANA ALTANA AG is an international pharmaceuticals and chemicals group with sales of about EUR 2.6 billion and more than 10,000 employees worldwide. Its pharmaceuticals group, ALTANA Pharma, concentrates on areas such as therapeutics and self-medication, and focuses on innovative pharmaceutical research in the areas of gastrointestinal, respiratory, and oncology. Located in Konstanz, Germany, ALTANA Pharma represents a group of 28 subsidiaries and associated companies in Europe, the Americas and Asia. ------------------------------------------------------------ Informasjonen er sendt gjennom Waymaker http://www.waymaker.no Nedenstående filer kan lastes ned: http://www.waymaker.net/bitonline/2004/10/27/20041027BIT20420/wkr0001.pdf Pressemeldingen i pdf-format