Dr. Reddy’s launch generic Fexofenadine HCl antihistamine tablets
14 Apr 2011
Hyderabad-based Dr. Reddy's Laboratories today said that it had entered the $452 million Fexofenadine market with the launch of its over-the-counter fexofenadine hydrochloride tablets.
The fexofenadine HCl Rx market had brand and generic sales of approximately $452 million for the 12 months ending 31 December 2010 according to IMS Health.
Sold by drug makers under trade names like Allegra, Telfast, Fastofen, Tilfur, Vifas, Telfexo, Allerfexo, fexofenadine is an antihistamine drug used in the treatment of hayfever and similar allergy symptoms.
India's second-largest pharma company after Ranbaxy, Dr Reddy's, said the US FDA had approved Dr Reddy's abbreviated new drug application (ANDA) for Fexofenadine HCl tablets on 12 April 2011.
Dr Reddy's product is the bioequivalent versions of Aanofi-Aventis' Allegra tablets, which received Rx-to-OTC switch approval from the FDA on 24 January 2011.
The Indian coompany will market the product under store brand labels in the US market.