PITTSBURGH, April 24, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg. This product is the generic version of Eli Lilly and Company's Zyprexa®, which 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. [1]
Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg, had U.S. sales of approximately $3.3 billion for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan is shipping this product immediately.
Currently, Mylan has 171 ANDAs pending FDA approval representing $97.2 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $25.7 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.
[1] There is an increased risk of death in elderly patients with dementia-related psychosis. Olanzapine is not approved for the treatment of patients with dementia-related psychosis. Close supervision of high-risk patients should accompany drug therapy when using in combination with fluoxetine. Other risks include neuroleptic malignant syndrome, increased blood sugars, increased blood lipids, tardive dyskinesia, low blood pressure, white blood cell abnormalities, seizures, impaired judgment, and elevated prolactin levels.
SOURCE Mylan Inc.
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