SPECTRUM RECEIVES FDA APPROVAL FOR CARBOPLATIN INJECTION ANDA
Spectrum Pharmaceuticals has received approval from the FDA's Office of Generic Drugs for its abbreviated new drug application for carboplatin injection in 50-, 150- and 450-mg multi-dose vials.
Carboplatin is a platinum-based, anti-cancer drug used in the treatment of patients with a wide variety of tumor types. The branded product, Paraplatin, is marketed by Bristol-Myers Squibb.
In April, Spectrum entered into an alliance with Cura Pharmaceuticals for the marketing and distribution of carboplatin injection in the U.S.