Hospira announces approval of new injection
LAKE FOREST — Hospira Inc., a generic injectable pharmaceuticals company, announced U.S. Food and Drug Administration approval of gemcitabine injection, a solution form of the drug.
The solution presentations include 200 mg, 1 gm and 2 gm with a concentration of 38 mg/mL. The oncology medication had U.S. sales of more than $750 million in 2010, led by Eli Lilly’s Gemzar. Hospira expects to launch the product in early September.
Hospira is the first company to offer gemcitabine in a solution formulation for the U.S. market. The solution formulation is designed to improve pharmacist convenience and handling safety. Its concentration is the same as the reconstituted strength of the available “freeze-dried” form. The solution versions, however, eliminate the need for reconstitution, improving workflow.
“Hospira is excited to offer U.S. pharmacists a solution form of gemcitabine that reduces preparation time,” said Thomas Moore, president, U.S., Hospira. “Hospira’s generic gemcitabine solution gives the medical community access to a lower-cost, more convenient offering of this key oncology drug.”
The approval follows the November 2010 launch of Hospira’s lyophilized, or freeze-dried formulation, gemcitabine HCL for injection — the first 2 gm presentation of the product — and the July 2011 launch of the standard freeze-dried formulation in 200 mg and 1 gm presentations. With the previous launches of the freeze-dried presentations, the company will offer the generic oncology drug in a range of strengths and forms for use.
Hospira’s specialty injectable pharmaceuticals 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-VantageT drug delivery system and iSecureT 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.