Generic of Extended-Release Ambien Approved

Actavis Group Oct. 18 announced that the Food and Drug Administration has approved its generic version of the extended-release version of the insomnia drug Ambien (zolpidem tartrate extended-release tablets).

Actavis said that, as the first company to file a generic application that contained a paragraph IV certification challenging the patent for Ambien CR 6.25 mg, it has been awarded 180-day exclusivity to market this product. Distribution of the product has commenced, the Morriston, N.J.-based company said.

Ambien CR was approved by FDA in 2005. In 2007, the maker of branded Ambien, Sanofi-aventis, sued several generic makers over their bids to ...