Ranbaxy receives tentative approval for generic antihistamine tablets

The tentative approval concerns the marketing and manufacturing of the fexofenadine hydrochloride tablets in 30mg, 60mg and 180mg doses. The drug is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children aged six years and above, the company said.

“This product represents a future opportunity for Ranbaxy and will be launched following final approval from the FDA. This will further expand our product portfolio of affordable generic alternatives which have a favorable impact on the economics of the US healthcare system,” said Jim Meehan, vice president of sales and marketing for Ranbaxy Pharmaceuticals.

Barr Pharmaceuticals and Teva Pharmaceutical Industries have both already launched generic versions of Sanofi-Aventis’ Allegra, but were sued by the French player in the process, as they took a different route to regulatory approval than Ranbaxy Pharmaceuticals’ chosen path.