Aurobindo Pharma receives final approval for Olanzapine Tablets

25 Apr 2012 Evaluate

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Olanzapine Tablets 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg (ANDA 091388). The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India.

Olanzapine Tablets 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg are the generic equivalent of Eli Lilly & Company’s Zyprexa Tablets 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg. Olanzapine Tablets are indicated for the treatment of serious psychotic disorders such as Schizophrenia and falls under the Neurological (CNS) therapeutic category. The annual sale of Olanzapine Tablets is approximately $3.2 billion and is ready for launch.

Aurobindo now has a total of 149 ANDA approvals (121 Final approvals including 1 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

Aurobindo Pharma has a product presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular, gastroenterology, etc. The company is the market leader in semi-synthetic penicillin drugs.

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