Hospira, Inc. (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today announced it has launched a two-gram vial of gemcitabine hydrochloride for injection. The oncology medication is a generic version of Eli Lilly's Gemzar®, which posted 2009 U.S. sales of nearly $750 million for the full range of standard presentations.
Hospira's gemcitabine is approved by the U.S. Food and Drug Administration (FDA) for treatment of a variety of cancers. Hospira will be the first and only company to offer gemcitabine in a two-gram vial for 180 days from the date of launch based on market exclusivity earned as the first company to file for this generic presentation of the drug.
"Hospira heard calls from physicians and pharmacists for a larger presentation of gemcitabine in line with dosing practices, and we've met their needs," said Thomas Moore, president, U.S., Hospira. "With this launch, we've expanded the availability of generic oncology offerings and added additional convenience for the medical community."
Regarding its filing for docetaxel, a generic version of Sanofi-Aventis's oncolytic Taxotere®, Hospira announced that its final label is pending FDA approval, which is expected at any time, but no later than within 10 business days.
"While Hospira cannot predict the timing for conversion to final approval, we have been working closely with the FDA and are confident the Agency understands the importance of delivering new, high-quality, cost-effective generic drugs to U.S. citizens as quickly as possible to increase patient access to treatment options and reduce the overall costs of healthcare," said Moore.
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.