Amerigen Announces U.S. FDA Approval For Generic Mixed Amphetamine Salts, Extended-Release Capsules
LYNDHURST, N.J., Jan. 24, 2019
LYNDHURST, N.J., Jan. 24, 2019 /PRNewswire/ -- Amerigen Pharmaceuticals Limited ("Amerigen") today announced that its Abbreviated New Drug Application ("ANDA") for a generic version of Shire's Adderall XR® (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, extended-release capsules) 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, has received final approval from the U.S. Food and Drug Administration. Amerigen's U.S. affiliate, Amerigen Pharmaceuticals Inc., is currently selling an authorized generic version of this product and plans to launch Amerigen's ANDA product in due course.
Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the U.S. and China. The group is controlled by Amerigen Pharmaceuticals Limited. The U.S. regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ. 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 U.S. and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the U.S. FDA and the Chinese CFDA. 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 U.S. FDA.
SOURCE Amerigen Pharmaceuticals