APP gets OK for Topotecan injection

SCHAUMBURG — APP Pharmaceuticals Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding Inc., announced today that it has received approval from the U.S. Food and Drug Administration to market Topotecan for injection, and plans to launch immediately.

Topotecan for injection is therapeutically equivalent to the reference-listed drug Hycamtin, which is marketed by GlaxoSmithKline.

Topotecan is used for small cell lung cancer sensitive disease after failure of first-line chemotherapy, and is 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 and is preservative-free.

“As one of the first generic entries into the market, APP's Topotecan for Injection will help reduce the cost of cancer treatment for patients who suffer from cervical and small cell lung cancers,” said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. “With the addition of Topotecan for Injection to our growing oncology portfolio, APP continues to demonstrate its ongoing commitment to expanding its presence in the oncology space.”