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news.Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application for Olanzapine tablets USP, 2.5mg, 5mg, 7.5mg, 10mg, 15mg, and 20mg.
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The company begins the shipment of the product, which is the generic equivalent to Eli Lilly and Company’s Zyprexa.
The product is indicated for the treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar 1 disorder and maintenance treatment of bipolar 1 disorder.
Olanzapine Tablets USP, 2.5mg, 5mg, 7.5mg, 10mg, 15mg, and 20mg, had US sales of approximately $3.3bn for the 12 months ending 31 December 2011, according to IMS Health.