APP Pharmaceuticals Receives US Approval for Cancer Drug

1 December 2010 (Last Updated December 1st, 2010 18:30)

APP Pharmaceuticals has received approval from the US Food and Drug Administration to market Topotecan for Injection, which is indicated for the treatment of small cell lung cancer and cervical cancer. The medication is therapeutically equivalent to the reference-listed drug Hycamtin,

APP Pharmaceuticals has received approval from the US Food and Drug Administration to market Topotecan for Injection, which is indicated for the treatment of small cell lung cancer and cervical cancer.

The medication is therapeutically equivalent to the reference-listed drug Hycamtin, which is currently marketed by GlaxoSmithKline.

The drug is indicated for the treatment of small cell lung cancer sensitive disease that has not responded to first-line chemotherapy, and in combination with Cisplatin for stage IV-B recurrent or persistent carcinoma of the cervix that has not responded to surgery or radiation therapy.

APP plans to launch Topotecan for Injection immediately in 4mg single-dose vials.