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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|Date:||Oct 19, 2010|
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