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Generic Tiazac Approved for Hypertension
Richard J. Lane, Andrx's Chief Executive Officer, remarked: "I am exceedingly pleased to announce this approval which we have anticipated receiving for a long time. Although we have maintained that our product was bioequivalent and stable, receiving final FDA approval ends all speculation. Simultaneous with this final marketing approval, we plan to launch all strengths of Taztia. We believe that Taztia will be a significant contributor to Andrx's 2003 operating results."
Though FDA awarded Andrx's ANDA a 180-day period of marketing exclusivity, that exclusivity period has expired.