Alvesco
Generic name: ciclesonide
Treatment for: Asthma
Aventis Receives Approvable Letter from U.S. Food and Drug Administration for Alvesco (ciclesonide) for Treatment of Persistent Asthma
BAD HOMBURG, Germany, and PARIS, France, October 26, 2004 – ALTANA AG (NYSE: AAA, FSE: ALT) and Aventis (NYSE:AVE), part of the sanofi-aventis Group, 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. ALTANA and Aventis 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.
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 EUR2.6 billion and more than 10,500 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 Constance, Germany, ALTANA Pharma represents a group of 28 subsidiaries and associated companies in Europe, the Americas and Asia.
Posted: October 2004
Related articles
- Alvesco Gains FDA Approval for the U.S. Market - January 16, 2008
- Aventis Submits New Drug Application to FDA for Asthma Drug Alvesco (ciclesonide) - January 1, 2004
Alvesco (ciclesonide) FDA Approval History
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