PITTSBURGH, May 14, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Olanzapine Orally Disintegrating Tablets (ODT), 5 mg, 10 mg, 15 mg and 20 mg, the generic version of Eli Lilly and Company's Zyprexa Zydis® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of schizophrenia or the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder.(1)
Olanzapine ODT, 5 mg, 10 mg, 15 mg and 20 mg, had U.S. sales of approximately $120.8 million for the 12 months ending March 31, 2014, according to IMS Health.
Currently, Mylan has 300 ANDAs pending FDA approval representing $105.3 billion in annual brand sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12 months ending Dec. 31, 2013, according to IMS Health.
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.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.