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

Aug

02
2016

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Lyndhurst NJ, USA. August 2, 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 Lysteda® (Tranexamic Acid 650mg instant release tablets). Amerigen had previously filed an ANDA for the product and made a Paragraph IV certification.

Ferring Pharmaceuticals Inc. markets Lysteda® in the U.S. to treat cyclic heavy menstrual bleeding. Pursuant to a 2015 agreement with Ferring B.V. and Ferring International Center S.A., Amerigen may launch its generic product under license at an undisclosed future date.

Amerigen noted that this is the 4th ANDA receiving either tentative or final FDA approval from its product development and manufacturing facility located in Suzhou, China.


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 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.