Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced U.S. FDA approval and launch of its topotecan hydrochloride for injection, a chemotherapy agent, in conjunction with the innovator's patent expiry. Sagent's topotecan is available in 4 mg single-dose latex-free vials. This is the latest product to feature Sagent's proprietary PreventIV Measures™ packaging and labeling that is designed to aid in product differentiation and to help with the reduction of medication errors. According to 2010 IMS data, the U.S. market for injectable topotecan approximated $158 million.
"Topotecan is an important treatment for patients who have recurrent small cell lung cancer sensitive disease or cervical cancer," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. "Our launch of topotecan reinforces Sagent's commitment to grow our oncology portfolio, to meet the needs of oncology patients and clinicians and to demonstrate our capabilities and expertise in injectable pharmaceuticals."