Dr Reddy’s launches OTC fexofenadine & pseudoephedrine ER tabs in US market
Dr Reddy’s Laboratories has launched its over-the-counter (OTC) Fexofenadine HCl and Pseudoephedrine HCl extended release tablets 180/240 mg. The Food & Drug Administration (FDA) approved Dr Reddy’s Abbreviated New Drug Application (ANDA) for Fexofenadine HCl and Pseudoephedrine HCl extended release tablets on June 22, 2011.
Dr Reddy’s will market the product under store brand labels in the US market. The product is a bioequivalent version of sanofi-aventis’ Allegra D24 Hour extended release tablets which received Rx-to-OTC switch approval from the FDA on January 24, 2011.