Teva Pharmaceutical Industries Ltd. has announced that the US Food and Drug Administration has granted tentative approval for the Company’s ANDA for Fexofenadine Hydrochloride Tablets, 30 mg, 60 mg and 180 mg.
Teva’s Fexofenadine HCl Tablets are the AB-rated generic equivalent of Aventis’ antihistamine Allegra Tablets, a product indicated for treatment of allergic rhinitis and chronic idiopathic urticaria.
Teva is currently involved in Paragraph IV litigation with Aventis concerning this product in the US District Court for the District of New Jersey.