LAKE FOREST, Ill., July 16, 2015 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, today announced it had obtained U.S. Food and Drug Administration (FDA) approval for the launch of bivalirudin for injection, a generic version of The Medicines Company's Angiomax™. Branded sales of Angiomax in 2014 in the United States were approximately $500 million.
Hospira's bivalirudin for injection is available in a single-dose flip-top vial, which matches the current branded offering available. In addition, the company plans to launch a differentiated presentation of the 250 mg bivalirudin for injection in Hospira's unique ADD-Vantage™ vial.
"Hospira is excited to launch the first generic of bivalirudin based on a successful challenge of the originator's patents," said Philippe Drouet, president, U.S. Commercial, Hospira. "This approval further demonstrates our commitment to bringing safe, lower-cost generic versions of important medications to the market as soon as possible."
Available as a lyophilized (powder) format, Hospira's bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients:
- With unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA);
- Undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the REPLACE-2 study;
- With, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI.
Bivalirudin is intended for use with aspirin.
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 the ADD-Vantage™ drug delivery system and Carpuject™ 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.
Important Safety Information
- Active major bleeding.
- Hypersensitivity to bivalirudin or any product components.
Warnings and Precautions
- Bleeding events: Hemorrhage can occur at any site. Discontinue bivalirudin for an unexplained fall in blood pressure or hematocrit.
- Coronary artery brachytherapy: Risk of thrombus formation, including fatal outcomes, in gamma brachytherapy.
Most common adverse reaction was bleeding (28 percent). Other adverse reactions (incidence >0.5 percent) were headache, thrombocytopenia and fever.
Limitation of use
Safety and effectiveness has not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill. Learn more at www.hospira.com.
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A Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or Hospira's future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these words or other similar terms or expressions that concern Hospira's expectations, strategy, plans or intentions. Forward-looking statements in this press release include Hospira's expectations regarding regulatory approvals, clinical trials and the actions of competitors. Hospira's expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, challenges inherent in creating and developing compounds and product candidates and economic, competitive, governmental, regulatory, legal, supply and other factors. Information on these and additional risks affecting Hospira's business and operating results are more fully discussed in the section entitled "Risk Factors" in Hospira's most recently filed annual report on Form 10-K and any subsequently filed quarterly report on Form 10-Q. The forward-looking statements in this press release are based on information available as of the date hereof, and Hospira disclaims any obligation to update any forward-looking statements, except as required by law.
SOURCE Hospira, Inc.