An approvable letter outlines specific questions that have to be resolved before the FDA will approve a product for marketing. The FDA’s questions in this letter relate specifically to Ambien CR (zolpidem tartrate extended release) and are not related to the safety and efficacy of the company’s insomnia treatment Ambien (zolpidem tartrate).
Sanofi-Aventis said that it is now working closely with the FDA to address the questions outlined in the letter.
The company’s blockbuster drug Ambien is indicated for the short-term treatment of insomnia and is marketed under the brand name Stilnox in Europe and as Myslee in Japan.
Sanofi-Aventis’ shares dipped by more than 1.5% in after-hours trading on the New York Stock Exchange following the news.