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Article: New Drug Application approved for once-daily Allegra-D.
- Article from:
- Biotech Business Week
- Article date:
- November 22, 2004
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2004 NOV 22 - (NewsRx.com & NewsRx.net) -- aaiPharma Inc. (NASDAQ: AAII) confirmed that 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 ...