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Amerigen Pharmaceuticals Limited today announced that its Abbreviated New Drug Application for cyclophosphamide capsules 25mg and 50mg has received final approval from the U.S. Food and Drug Administration

Amerigen Pharmaceuticals
Posted on: 20 Mar 18
Amerigen Pharmaceuticals Limited today announced that its Abbreviated New Drug Application for cyclophosphamide capsules 25mg and 50mg has received final approval from the U.S. Food and Drug Administration

PR Newswire

LYNDHURST, N.J., March 20, 2018

LYNDHURST, N.J., March 20, 2018 /PRNewswire/ -- Amerigen Pharmaceuticals Limited ("Amerigen") today announced that its Abbreviated New Drug Application ("ANDA") for cyclophosphamide capsules 25mg and 50mg has received final approval from the U.S. Food and Drug Administration. Amerigen believes that its ANDA is the first to be approved as a generic equivalent to West-Ward Pharmaceuticals' corresponding U.S. reference listed drug. Amerigen's generic cyclophosphamide capsules are manufactured by Stason Pharmaceuticals, Inc. in Irvine, CA. Amerigen's U.S. affiliate, Amerigen Pharmaceuticals, Inc., expects to launch the product in the near future. Cyclophosphamide is an anti-neoplastic agent used in the treatment of various cancers.

About Amerigen

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 Lyndhurst, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceutical Company Limited, is located in Suzhou, Jiangsu Province. The group has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese CFDA. Amerigen's focus is orally delivered products that are potential first generics, 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.

Contact Information: Michelle Valsera. Telephone (732) 993-9821 or info@amerigenpharma.com

View original content:http://www.prnewswire.com/news-releases/amerigen-pharmaceuticals-limited-today-announced-that-its-abbreviated-new-drug-application-for-cyclophosphamide-capsules-25mg-and-50mg-has-received-final-approval-from-the-us-food-and-drug-administration-300616936.html

SOURCE Amerigen Pharmaceuticals

PR Newswire
www.prnewswire.com

Last updated on: 20/03/2018

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