Amerigen Pharmaceuticals Limited announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Temodar® (temozolomide capsules 5, 20, 100, 140, 180 and 250mg).
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The product has been launched and is manufactured by Stason Pharmaceuticals, Inc.
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(“Stason”) in Irvine, CA and is the first approval from the previously announced 2011 collaboration between Amerigen and Stason to develop a portfolio of oral oncology products.
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