Home » FDA Grants Tentative Approval to Teva's Generic Ambien
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.
KEYWORDS Drug Pipeline Alert
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