The Hindu Business Line : Ranbaxy gets USFDA nod to sell insomnia drug

New Delhi March 16 Ranbaxy Laboratories said on Friday it has received tentative US Food and Drug Administration's (FDA) approval to make and sell Zolpidem Tartrate tablets prescribed in the treatment of insomnia. The approval is for two strengths of the drug, 5mg and 10mg.

The company will make the generic version of the `Sanofi Aventis', registered drug Ambien, at its New Jersey facility, Ohm Laboratories Inc.

The French company, among the five largest pharma companies in the world, also sells Ambien as Stilnox in more than 100 countries outside the US, including France where it's the market leader, and as Myslee in Japan.

The annual market sales for Zolpidem Tartrate tablets were at $2.12 billion for 2006. For Sanofi Aventis the drug's among its top three blockbusters, with sales of about $2,670 million, and was one of its best performer with 33.3 per cent growth in sales.

"The 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 Mr Jim Meehan, Vice-President of Sales and Marketing, for the company's US subsidiary, Ranbaxy Pharmaceuticals Inc.

The FDA had recently requested drugmakers to use stronger warnings on the labels of sleep disorder drugs against possible side effects.

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