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USFDA nod for Dr Reddy's Zolpidem

Our Bureau

Hyderabad, April 25

Dr Reddy's Laboratories Ltd has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Zolpidem Tartrate tablets, 5 mg and 10 mg. The product is being shipped immediately, according to a press release issued here on Wednesday.

Zolpidem Tartrate tablets are the generic version of Sanofi-Aventis Ambien tablets. Ambien tablets had US sales of approximately $2.1 billion for the same strengths for 2006 according to IMS Health, the release added.

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