Company received tentative approval for generic Zolpidem Tartrate tablets.
Ranbaxy Laboratories received tentative approval to manufacture and market a generic version of Ambien®. Sanofi-aventis’ short-term treatment of insomnia and related disorders made $2.12 billion in 2006, according to Ranbaxy.
“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,” states Jim Meehan, vp of sales and marketing for Ranbaxy Pharmaceuticals.
The Office of Generic Drugs, FDA, determined the Ranbaxy formulations of Zolpidem Tartrate tablets, 5mg and 10mg, were bioequivalent and have the same therapeutic effect as that of Ambien tablets 5mg and 10mg.
The products will be manufactured at the company’s Ohm Laboratories facility based in North Brunswick, NJ.