FDA Grants Ranbaxy Tentative Approval for Insomnia Drug
Posted on: Friday, 16 March 2007, 12:00 CDT
Ranbaxy Laboratories has received tentative approval from the FDA to manufacture and market a generic version of Sanofi-Aventis' insomnia drug Ambien.
Ranbaxy said that it plans to manufacture the zolpidem tartrate tablets in 5mg and 10mg strengths. The products will be manufactured at the company's New Jersey Ohm Laboratories facility.
Total annual market sales for zolpidem tartrate tablets were $2.12 billion, according to Ranbaxy.
"This product will be launched following final approval from the FDA and presents yet another opportunity for Ranbaxy to expand its product portfolio by offering an affordable generic alternative," said Jim Meehan, vice president of sales and marketing for Ranbaxy Pharmaceuticals in the US.
Source: Datamonitor
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