Pharmaceutical and biotechnology firm Wockhardt today said it has received tentative approval from the US Food & Drug Administration (USFDA) to sell generic version of Sanofi Aventis’ Allegra-D, used for treating allergic rhinitis.
In a statement the company said it has received tentative approval from the USFDA) for marketing the Fexofenadine HCl 60mg + Pseudoephedrine HCL 120mg extended release tablets which is used for treatment of seasonal allergic rhinitis without causing drowsiness.
Fexofenadine plus Pseudoephedrine is the generic name for the brand Allegra-D® 12 hour, marketed in the US by Sanofi Aventis.
“The patent covering this product is under litigation in the US courts and Wockhardt will launch the product after resolution of the same,” it said.
Commenting on the development, Wockhardt Chairman Habil Khorakiwala said : “Wockhardt is amongst only four companies to have received US FDA approval for this drug which is the most prescribed antihistamine plus decongestant product.”
This is yet another extended release product from the R&D pipeline of Wockhardt and the fourth such product to be approved by the US FDA in the yea, he added.
Citing figures from global information services and publishing firm Wolters Kluwer, Wockhardt said the total market for the drug in the US is about USD 214 million.
The tablets will be manufactured at the USFDA certified formulation plant at Waluj, Aurangabad and the Fexofenadine HCl active pharmaceutical ingredient will be manufactured in the FDA certified API plant at Ankleshwar, Gujarat, the company said.
Wockhardt scrip was trading at Rs 321.25 per share on the Bombay Stock Exchange in the afternoon trade, up by 1.66 per cent from the previous close.