Unichem receives US FDA nod for prostate drug alfuzosin

Unichem Laboratories Ltd on January 29, 2016 received final approval from the US Food & Drug Administration (FDA) for alfuzosin hydrochloride extended release tablet. The new product is the company’s first Para IV ANDA approval from the US FDA.
 
Alfuzosin hydrochloride extended release tablet, a generic version of Concordia Pharmaceuticals’ Uroxatral tablet, is used in treating prostatic hyperplasia.
 
The product will be commercialised from Unichem's Goa plant, while the active pharmaceutical ingredients (API) for the product would also be made in-house at Pithampur plant.