RANBAXY WINS TENTATIVE APPROVAL FOR GENERIC AMBIEN

Ranbaxy Laboratories announced it has received tentative approval from the FDA to manufacture and market generic zolpidem tartrate tablets, 5 and 10 mg.

The FDA found Ranbaxy's product to be bioequivalent and to have the same therapeutic effect as sanofi-aventis' Ambien.

Ambien is indicated for the short-term treatment of insomnia and related disorders, Ranbaxy said. The drug had total annual sales of $2.12 billion last year, according to the company.

"This product will be launched following final approval from the FDA and presents yet another opportunity for Ranbaxy to expand its product portfolio by offering an affordable generic alternative," Jim Meehan, Ranbaxy's vice president of sales and marketing, said.