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Aventis Submits New Drug Application With U.S. Food and Drug Administration For
Once Daily Formulation of Allegra-D(R) (fexofenadine HCl 180 mg/pseudoephedrine
HCl 240 mg)
STRASBOURG, France, Dec. 29 /PRNewswire-FirstCall/ -- Aventis announced today
the submission of a new drug application (NDA) to the U.S. Food and Drug
Administration (FDA) for Allegra-D 24 hour tablets (fexofenadine HCl 180
mg/pseudophedrine HCl 240 mg). The company is seeking marketing approval for a
once daily formulation for the treatment of seasonal allergy symptoms with nasal
congestion in adults and children 12 years of age and older. Aventis currently
markets twice daily Allegra-D (fexofenadine HCl 60 mg/pseudoephedrine HCl 120
mg) extended release tablets.
As many as 40 million adults and children in the United States suffer from
seasonal allergies and associated symptoms, such as nasal congestion, watery
eyes, runny nose, sneezing and itchy throat. They are caused by the body's
reaction to allergens. Symptoms typically occur in the spring and fall when
large amounts of allergens, such as pollen, are in the air.
"Seasonal allergic rhinitis is a chronic condition that requires appropriate
treatment," said Frank Ciriello, Vice President, Respiratory Sales and
Marketing. "This submission represents our continued commitment to innovate
with the established Allegra family of products to provide relief to the
millions of Americans suffering from seasonal allergies."
Side effects with Allegra-D (fexofenadine HCl 60 mg/pseudophedrine HCl 120 mg)
extended release tablets were similar to Allegra alone and may include headache,
insomnia, and nausea. Due to the decongestant (pseudoephedrine) component in
Allegra-D, this product must not be used if you: are taking an MAO inhibitor (a
medication for depression) or have stopped taking an MAO inhibitor within 14
days; retain urine; have narrow-angle glaucoma; have severe high blood pressure
or severe heart disease.
You should also tell your doctor if you have high blood pressure, diabetes,
heart disease, glaucoma, thyroid disease, impaired kidney function, or symptoms
of an enlarged prostate such as difficulty urinating.
About Aventis
Aventis is dedicated to treating and preventing disease by discovering and
developing innovative prescription drugs and human vaccines. In 2002, Aventis
generated sales of euro 17.6 billion (US $16.6 billion), invested euro 3.1
billion (US $3 billion) in research and development and employed approximately
71,000 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 about Aventis in the U.S., please visit:
http://www.aventis-us.com/.
To receive a copy of this release or any recent release, visit the Aventis
Pharmaceuticals U.S. Web site at http://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 "Commission des Operations de Bourse" in
France, recently renamed "Autorite des marches financiers".
DATASOURCE: Aventis
CONTACT: Corinne Hoff, Global Media Relations, +33-3-88-99-19-16,
, Bethann Coyle, Global Product Communications,
+1-908-231-5824, , Lise Geduldig, U.S. Product
Communications, +1-908-243-6580, , or Melissa
Feltmann, U.S. Product Communications, +1-908-243-7080,
, all of Aventis
Web site: http://www.aventis-us.com/