Dr Reddy’s launches OTC generic of Sanofi's Allegra
31 Aug 2011
Dr Reddy announces the launch of over-the-counter (OTC) fexofenadine HCI and pseudoephedrine HCI extended release tablets 180 /240 mg, the company said in a filing with the Bombay Stock Exchange.
The US FDA approved Dr. Reddy's abbreviated new drug application (ANDA) for Fexofenadine HCl and Pseudoephedrine HCl extended release tablets on 22 June, 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.
Sanofi-Aventis received Rx-to-OTC switch approval from the FDA on January 24th, 2011 and launched the allergy drug in the US as an OTC in March 2011.
According to Dr Reddy's stck exchange filing Allegra provides fast, non-drowsy, 24-hour relief from indoor and outdoor allergy symptoms including itchy, sneezing, and watery eyes and a runny or congested nose called as seasonal allergic rhinitis–commonly known as hay fever.