Ranbaxy gets USFDA nod to market ZOlpidem Tartrate tablets

New Delhi, Mar 16 (UNI) Ranbaxy Laboratories Ltd today said it has received tentative approval from the United States Food and Drug Administration (USFDA) to manufacture and market Zolpidem Tartrate tablets.

The administration has determined the Ranbaxy formulations to be bioequivalent to that of Ambien tablets of Sanofi Aventis US, LLC.

The products will be manufactured at the company's Ohm Laboratories Inc facility, in New Jersey.

The total annual market sales for Zolpidem Tartrate tablets are nearly 2.12 billion dollars, according to IMS.

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 Ranbaxy Pharmaceuticals Inc Vice President (Sales and Marketing) Jim Meehan.

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

UNI