Aventis Announces FDA Approval of Nasacort(reg) HFA (triamcinolone acetonide) Nasal Aerosol

Main Category: Allergy
Article Date: 16 Apr 2004 - 0:00 PDT


Aventis today announced that the U.S. Food and Drug Administration (FDA) has approved Nasacort HFA (triamcinolone acetonide) Nasal Aerosol for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children age 6 and older. Nasacort HFA Nasal Aerosol is the first intranasal corticosteroid dry-aerosol formulation approved in the U.S. that contains hydrofluoroalkane (HFA), rather than chlorofluorocarbons (CFCs).

First HFA Nasal Aerosol Available to Treat Nasal Allergy Symptoms
Aventis Pharmaceuticals Inc. Press Release

Nasacort HFA Nasal Aerosol will provide physicians and patients with a new option for those seeking a dry-aerosol formulation for the management of nasal allergy symptoms. It replaces Nasacort(reg) Nasal Inhaler, which was taken off the market in July 2003 to comply with Environmental Protection Agency (EPA) and FDA requirements intended to protect the ozone layer and that required the removal of nasal inhalers containing CFCs from the U.S. market.

In placebo controlled clinical trials, the most commonly reported side effects were sneezing, headache, nasal irritation and rhinitis.

About Aventis

Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of £16.79 billion (US $18.99), invested £2.86 billion (US $3.24) in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information, please visit: www.aventis-us.com.

Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report -"Document de Reference"- on file with the "Autorite des marches financiers" in France.

From:
http://www.aventis.com/main/page.asp?pageid=10352320040415153652&lang=en

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