Mumbai: Ranbaxy Laboratories Ltd has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market zolpidem tartrate tablets, 5mg and 10mg.
The office of Generic Drugs, USFDA, has determined the Ranbaxy formulations to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Ambien tablets 5mg and 10mg of Sanofi Aventis US, LLC.
The products will he manufactured at the Ranbaxy's Ohm Laboratories Inc. facility, based in North Brunswick, New Jersey, USA. zolpidem tartrate tablets had total annual market sales of.$12 Bn (IMS - Q4 - 2006).
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia and related disorders.
"We are pleased to receive this tentative approval for zolpidem tartrate tablets. 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," said Jim Meehan, vice president of sales and marketing for Ranbaxy Pharmaceuticals Inc., USA.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories, India's largest pharmaceutical company by sales.
RPI is engaged in the sale and distribution of generic and branded prescription products in the US.