APP Pharmaceuticals Inc. is a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding Inc. focused on the development, manufacture and marketing of injectable pharmaceutical products for the oncology, anti-infective, anesthetic and critical care markets.
The company today announced it has received approval from the U.S. Food and Drug Administration (FDA) to market Topotecan for Injection. The company said it plans to launch the product immediately and anticipates expanding its position in the oncology arena.
Topotecan for Injection is indicated for use in small cell lung cancer sensitive disease when the first-line of chemotherapy has failed. It has also received clearance for use in combination therapy with Cisplatin for stage IV-B, as well as for recurrent or persistent carcinoma of the cervix.
APP’s Topotecan for Injection will enter the market as one of the first generic injectables of its kind. Topotecan is therapeutically equivalent to GlaxoSmithKline’s currently marketed drug Hycamtin®.
John Ducker, president and CEO of APP, noted the importance of a generic form of the product, as well as its value to APP’s product portfolio.
“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,” Ducker stated in the press release. “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.”
For more information, visit www.fresenius-kabi.com or www.APPpharma.com
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