FDA approves Hospira's meropenem for injection, USP (I.V.)

Hospira, Inc. (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today announced it has received U.S. Food and Drug Administration (FDA) approval for meropenem for injection, USP (I.V.) 500 mg and 1 g vials.  The medication, a carbapenem that belongs to the beta-lactam class of antibiotics, is a generic version of AstraZeneca's Merrem® I.V. Sales of the name-brand product in the United States were approximately $200 million in 2009.

"This is the first generic carbapenem approved in the United States, and will help propel Hospira to a position of leadership in this category of antibiotics," said Thomas Moore, president, Hospira, U.S. Region. "Hospira is committed to continuing to reduce the cost of healthcare spending by providing savings with first-to-market generic launches."

Meropenem represents the first U.S. drug launch from Hospira's recent acquisition of the generic injectables business of Orchid Chemicals & Pharmaceuticals, Ltd. Beta-lactam antibiotics represent a class of drugs with a wide spectrum of antibacterial activity. The U.S. market value of beta-lactam molecules is more than $1 billion, based on 2009 sales, according to IMS Health.

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 biogeneric drugs.