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Article: New Drug Application Approved For Once-Daily Allegra-D Formulation Using aaiPharma's Development Expertise.
- Article from:
- Business Wire
- Article date:
- October 26, 2004
CopyrightCOPYRIGHT 2004 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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WILMINGTON, N.C. -- aaiPharma Inc. (NASDAQ: AAII) today confirmed the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for Aventis' new Allegra-D 24 Hour tablets (fexofenadine HCl 180 mg / pseudoephedrine HCl 240 mg), a formulation developed with aaiPharma and Osmotica Pharmaceutical.
Allegra-D 24 Hour tablets are approved for the treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older. Allegra-D 24 Hour is the only approved once daily prescription antihistamine with a decongestant.
Under the terms of the agreement, aaiPharma will receive a one time payment from ...