Nov 30, 2010 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Topotecan for Injection, and plans to launch immediately.Topotecan for Injection is therapeutically equivalent to the reference-listed drug Hycamtin(R), which is currently marketed by the innovator GlaxoSmithKline, plc. According to IMS data, U.S. sales of Hycamtin(R), in 2009 were $157.1 million.
Topotecanfor Injection is indicated for small cell lung cancer sensitive disease after failure of first-line chemotherapy, and is also indicated for use in combination therapy with Cisplatin for stage IV-B, and for recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. APP will market Topotecanfor Injection in 4 mg single dose vials; the product is bar-coded and preservative-free... APP Pharmaceuticals' Press Release -
