Aurobindo Pharma Ltd. announced that the company had obtained final approvals from the US FDA to manufacture and market Olanzapine tablets 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg covered under ANDA 091388.
Olanzapine tablets 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg are the generic equivalent of Eli Lilly and 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 company said the product was ready for launch. The annual sale of Olanzapine tablets is around $3.2 billion.
The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India.
The company now has a total of 149 ANDA approvals (121 Final approvals including one from Aurolife Pharma LLC and 28 Tentative approvals) from US FDA.
At the BSE, Aurobindo Pharma closed Wednesday's trading at Rs.127, down 1.89 percent from the previous close.
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