Dr Reddy’s Laboratories has launched its Over-The-Counter (OTC) fexofenadine HCl tablets on April 13, 2011. The Food & Drug Administration (FDA) approved Dr Reddy’s Abbreviated New Drug Application (ANDA) for fexofenadine HCl tablets on April 12, 2011.
Dr Reddy’s will market the product under store brand labels in the US market. The products are bioequivalent versions of sanofi-aventis’ Allegra tablets which received Rx-to-OTC switch approval from the FDA on January 24th, 2011. The fexofenadine HCl Rx market had brand and generic sales of approximately $452 million for the twelve months ending December 31, 2010 according to IMS Health.