Amerigen Pharmaceuticals Limited announces that its ANDA for carbidopa 25mg tablets has received final approval from the U.S. Food and Drug Administration
, March 12, 2014
/PRNewswire/ -- Amerigen Pharmaceuticals Limited announces that its ANDA for carbidopa 25mg tablets has received final approval from the U.S. Food and Drug Administration. The product is a generic equivalent of Valeant's Lodosyn® and has been launched under an Amerigen Pharmaceuticals label.
John Lowry, Amerigen's President & CEO commented: "We are very pleased to receive our first ANDA approval. This product was entirely self-developed and manufactured by Amerigen and is the first ANDA approved for which Lodosyn® is the reference listed drug. We look forward to further approvals this year and transitioning our pipeline of filed ANDA's into a commercial portfolio of specialty generic 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. 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, the Suzhou Amerigen Pharmaceutical Company 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. 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.
SOURCE Amerigen Pharmaceuticals