Hospira, Inc. (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today announced U.S. Food and Drug Administration (FDA) approval of docetaxel. The medication is a generic version of Sanofi-Aventis's Taxotere®, and Hospira expects to launch the product later this month.
Hospira's docetaxel is approved for the treatment of a variety of cancers. In 2010, U.S. sales of Taxotere were approximately $1.2 billion.
Unlike original product formulations that require healthcare workers to take a two-step process prior to infusion, Hospira's docetaxel comes in a single-vial formulation that is designed to reduce the number of handling steps in the preparation of the product.
"Hospira's docetaxel will give U.S. cancer patients access to a high-quality, lower-cost alternative to the branded product, offers a differentiated delivery system designed to enhance caregiver safety, and reinforces Hospira's commitment to meet patient and caregiver needs in the oncology space," said Thomas Moore, president, U.S., Hospira.
Hospira will offer 20 mg, 80 mg and 160 mg vials of docetaxel at a 10 mg/mL concentration, the original concentration that customers have used safely for many years. Hospira already markets docetaxel in Europe and Australia.
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.