Olanzapine is the generic equivalent of Zyprexa for treatment of schizophrenia and acute bipolar mania.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the company's abbreviated new drug application (ANDA) for Olanzapine tablets, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg.
Teva's Olanzapine tablets are the AB-rated generic equivalent of Eli Lilly and Co.'s psychotropic agent Zyprexa tablets. Zyprexa is used in the treatment of schizophrenia and acute bipolar mania.
Teva noted that final approval was subject to the resolution of patent litigation, and the expiration of any applicable exclusivity period enjoyed by another ANDA filer.
Published by Globes [online], Israel business news - www.globes.co.il - on Monday, March 28, 2005