Ranbaxy gets tentative FDA nod for FH tablet

Mumbai, May 18: Ranbaxy Laboratories Ltd has announced that the company has received tentative approval from the US Food and Drug Administration (FDA) to manufacture and market Fexofenadine Hydrochloride tablets of 30 mg, 60 mg and 180 mg.

The total annual market sales for Fexofenadine Hydrochloride tablets have been USD 931 million.

''We are pleased to receive this tentative approval for Fexofenadine Hydrochloride Tablets. 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 that is anticipated to have a favorable impact on the economics of the US healthcare system,'' said Ranbaxy Pharmaceuticals Inc (RPI) Vice President (Sales and Marketing) Jim Meehan in a statement here today.

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children of 6 years of age and older. Symptoms treated effectively are sneezing, rhinorrhea, itchy nose or palate or throat, itchy watery or red eyes.

Ranbaxy Pharmaceuticals Inc (RPI) based in Jacksonville, Florida, is a wholly-owned subsidiary of the company. RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.

UNI