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Actavis gets FDA approval to market Zolpidem Tartrate Extended-Release Tablets.

M2 PHARMA-October 19, 2010-Actavis gets FDA approval to market Zolpidem Tartrate Extended-Release Tablets(C)2010 M2 COMMUNICATIONS

19 October 2010 - Iceland-based generic pharmaceuticals company Actavis Group announced yesterday it has received approval from the US Food and Drug Administration (FDA) to market Zolpidem Tartrate Extended-Release Tablets, USP 6.25mg CIV.

Distribution of the product has commenced.

As the first company to file an ANDA that contained a paragraph IV certification for Ambien CR 6.25mg, Actavis has been awarded 180-day exclusivity to market this product.

Zolpidem Tartrate Extended-Release Tablets 6.25mg, the generic equivalent of Ambien CR 6.25mg by sanofi-sventis, had US sales of approximately USD129m (EUR92.7m) for the 12 months ending 30 June 2010, according to IMS Health.

(USD1 = EUR0.719)

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Publication:M2 Pharma
Geographic Code:4EXIC
Date:Oct 19, 2010
Words:135
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