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Ranbaxy gets nod for Ambien

Our Bureau

New Delhi, April 27

Ranbaxy Laboratories has received approval from the US Food and Drug Administration to manufacture and market generic versions of the insomnia drug, Ambien. The approval is for 5mg and 10mg tablets of Zolpidem Tartrate, the company said in an e-mailed statement. According to the company, the Office of Generic Drugs, US FDA, has determined Ranbaxy's formulation to be bioequivalent to Sanofi Aventis' registered drug Ambien. The product is to be manufactured at the company's New Jersey facility, Ohm Laboratories. The annual market sales of the drug in the US are estimated at $2.12 billion, according to Ranbaxy.

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