FDA approves Hospira's topotecan for SCLC

Hospira, Inc. (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today announced U.S. Food and Drug Administration (FDA) approval of Topotecan Injection, the first solution formulation of the oncology drug approved in the United States. The medication is a generic version of Hycamtin®, which had 2010 U.S. sales of more than $140 million. Hospira's topotecan is indicated for treatment of small cell lung cancer (SCLC) sensitive disease after failure of first-line chemotherapy.  

The solution formulation of topotecan, with a concentration of 4 mg/4 ml, is designed to improve caregiver convenience and safety, and Hospira expects to launch the product by the end of February.

"Hospira's solution version of topotecan expands our portfolio of value-added generics," said Thomas Moore, president, U.S., Hospira. "We're excited to offer the medical community access to a lower-cost, more convenient version of this key oncolytic."

Hospira's specialty injectable pharmaceuticals (SIP) offering includes approximately 200 generic injectable drugs in many dosages and formulations. In addition, many of its products are available in popular differentiated presentations, several of which are proprietary, such as ADD-Vantage™ drug delivery system and iSecure™ prefilled syringes. Therapeutic segments include analgesia, anesthesia, anti-infectives, cardiovascular, oncology, emergency and other areas. Hospira also has robust pipelines of both generic and biosimilar drugs.