AMERIGEN announces final approval from FDA for generic version of Temodar®

Aug

18
2016

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CHINA CONTACT: +86-512-6745-1085 ext 101
info@amerigenpharma.com


Lyndhurst NJ, USA. August 19, 2016 – Amerigen Pharmaceuticals Limited (“Amerigen”) today 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.


About

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. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in East Brunswick, NJ, USA. The group’s Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Limited, is located in Suzhou, Jiangsu Province. The group has an active portfolio of products under development, filed, or intended for filing, as ANDA’s with the US FDA and the Chinese SFDA. 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. All Amerigen’s products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.