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SCHAUMBURG, Ill. — The Food and Drug Administration has approved a generic chemotherapy drug made by Sagent Pharmaceuticals, Sagent said Thursday.
The FDA approved topotecan hydrochloride for injection, a version of GlaxoSmithKline’s Hycamtin. The U.S. market for injectable topotecan was around $158 million in 2010, according to IMS Health.
“Topotecan is an important treatment for patients who have recurrent small-cell lung cancer sensitive disease or cervical cancer,” Sagent chairman and CEO Jeffrey Yordon said. “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.”