Tentative approval for generic anti-cancer compound carboplatin
LOS ANGELES, CA -- American Pharmaceutical Partners announced it has received tentative approval from the FDA of its Abbreviated New Drug Application for carboplatin injection in single-dose vials containing 50 mg, 150 mg or 450 mg.
Carboplatin is indicated for initial as well as secondary treatment of ovarian cancer, and is the generic equivalent of Bristol-Myers Squibb's Paraplatin. FDA found APP's carboplatin to be safe and effective, however APP will not receive final approval, and thus may not market its product, until the innovator's period of patent protection expires on April 14, 2004.
Posted: April 2004