AMERIGEN Announces Final Approval From FDA For Generic Version of Temodar®
- September 16, 2016
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Amerigen Pharmaceuticals Limited (“Amerigen”) 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). The product has been launched and is manufactured by Stason Pharmaceuticals, Inc. (“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.