Indian drug major Ranbaxy Laboratories Ltd says it has obtained tentative approval from the US Food and Drug Administration to manufacture and market a drug for insomnia.
The US unit of the company announced Friday that the Office of Generic Drugs, US FDA, has determined the Ranbaxy formulations of Zolpidem Tartrate tablets to be bioequivalent and to have the same therapeutic effect as that of Ambien tablets of Sanofi Aventis US, LLC.
Zolpidem Tartrate tablets are indicated for the short-term treatment of insomnia and related disorders. As per latest data, the total annual market sales for Zolpidem Tartrate tablets were $2.12 billion.
Ranbaxy said the new drug would be manufactured at the company's Ohm Laboratories Inc. facility, based in North Brunswick, New Jersey, USA.
The vice president of sales and marketing of Ranbaxy Pharmaceuticals Inc., USA, Jim Meehan, said that the product would be launched following final approval from the FDA. This would give yet another opportunity for Ranbaxy to expand its product portfolio by offering an affordable generic alternative, he added.
The Jacksonville, Florida-based Ranbaxy Pharmaceuticals Inc. is a wholly owned subsidiary of the company. RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.