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news.The US Food and Drug Administration (FDA) has approved APP Pharmaceuticals, a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals, to market Topotecan for Injection, and plans to launch immediately.
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APP Pharma claims that Topotecan for injection is therapeutically equivalent to the reference-listed drug Hycamtin, which is currently marketed by the GlaxoSmithKline.
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 Pharma will market Topotecanfor injection in 4mg single dose vials; the product is bar-coded and preservative-free.
APP Pharma president and CEO John Ducker said that 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.
"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," Ducker said.