Amerigen Pharmaceuticals Limited announced that the US 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.
Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. Amerigen's focus is orally delivered products that are challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market.