FDA Approves Generic Cyclophosphamide for Injection
4 June 2018 - - Bridgewater, New Jersey-based integrated specialty pharmaceutical company Amneal Pharmaceuticals (NYSE: AMRX) has received US Food and Drug Administration approval on its abbreviated new drug application for cyclophosphamide for injection, the therapeutic equivalent to Cytoxan, the company said.
Cyclophosphamide for injection USP, 500 mg, 1 g and 2 g had annual US generic sales of approximately USD332m according to IQVIA for the 12 months ending April 2018.
Amneal is focused on developing, manufacturing and distributing generic, brand, and biosimilar products.
With approximately 6,500 employees in North America, Asia, and Europe, Amneal possesses an expanding portfolio of generic products to include complex dosage forms in a broad range of therapeutic areas.
Through its Impax specialty pharmaceutical division, focused principally on central nervous system disorders and parasitic infections, the company markets branded products.