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Dr Reddy's Laboratories Ltd announced on Tuesday that it has launched its over the counter (OTC) Fexofenadine HCl and Pseudoephedrine extended HCl release tablets 180/240 mg.
The US Food & Drug Administration (FDA) approved Dr Reddy's Abbreviated New Drug Application (ANDA) for Fexofenadine HCl and Pseudophendrine HCl extended release on June 22.
According to a statement made to the stock exchanges, Dr Reddy's plans to 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 FDA on January 24, 2011.
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