FDA Grants Tentative Approval to Teva's Generic Ambien

Teva Pharmaceutical has received FDA approval for its zolpidem tartrate tablets in 5-mg and 10-mg doses.

The tablets are the generic version of sanofi-synthelabo's Ambien tablets, which are indicated for the short-term treatment of insomnia. Teva expects final approval of the tablets when sanofi-synthelabo's patent covering Ambien tablets expires in October 2006.