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Article: New Drug Application Submitted for Once-Daily Allegra-D(R) (fexofenadine HCl 180 mg/pseudoephedrine HCl 240 mg) Formulation Using aaiPharma's Development Expertise.

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PR Newswire
Article date:
January 15, 2004
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aaiPharma Inc., today confirmed Aventis' submission of a new drug application (NDA) to the FDA for Aventis' Allegra-D 24 hour tablets (fexofenadine HCl 180 mg/pseudoephedrine HCl 240 mg), a formulation developed with aaiPharma using a patented extended release drug delivery technology, ProSlo II(TM), developed by Osmotica. Aventis is seeking 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.

The once-daily technology platform used ...

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