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New Drug Application Submitted for Once-Daily Formulation of Fexofenadine

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.

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