Hospira gains US approval of solution version of gemcitabine injection

US generic injectable drug leader Hospira (NYSE: HSP) says the US Food and Drug Administration has approved its gemcitabine injection, a solution form of the drug. The cancer drug, Eli Lilly’s (NYSE: LLY) Gemzar brand, had US sales of more than $750 million in 2010, but lost patent protection last November and generated global sales of just $112 million for Lilly in the second quarter of this year. Hospira expects to launch the product in early September. The news saw Hospira’s shares rise 3% to $48.48.

Hospira is the first company to offer gemcitabine in a solution formulation for the US market. It launched a two-gram vial of gemcitabine hydrochloride for injection. 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, said Hospira.

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.