Amerigen Pharmaceuticals announced 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 in Irvine, CA. Amerigen’s U.S. affiliate, Amerigen Pharmaceuticals expects to launch the product in the near future. Cyclophosphamide is an anti-neoplastic agent used in the treatment of various cancers.