|Baxter Announces U.S. FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin|
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"The approval of bivalirudin demonstrates how Baxter brings its
innovative technologies together with medicines in ways that help
promote efficiency for clinicians," said
Bivalirudin will use Baxter's proprietary frozen GALAXY container technology, a non-PVC and non-DEHP system specifically designed to create a ready-to-use format for unstable molecules. Premixed versions of commonly prescribed drugs help simplify the preparation process and can avoid potential errors that may occur when medications are compounded. Compounding is the process of combining different ingredients in specific quantities to fill individualized prescriptions.
Baxter's premixed medications are manufactured to current Good
Manufacturing Practice (cGMP) regulations established and monitored by
Baxter provides a wide range of high-value generic injectable medicines that help treat some of the most pressing healthcare needs facing patients today, including difficult-to-manufacture oncology drugs and standard-dose, ready-to-use premixed injectable anti-infectives, analgesics and critical care medicines. Baxter has rapidly expanded its pharmaceuticals portfolio through recent acquisitions, strategic partnerships and internal development programs that will help increase access to essential medicines and advance pharmacy efficiency and patient care. Baxter is also the first and only company to offer all three of the most commonly used modern inhaled anesthetics for general anesthesia.
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Indications and Usage for BIVALIRUDIN in 0.9% Sodium Chloride Injection, for intravenous use
Bivalirudin Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).
Important Risk Information for BIVALIRUDIN in 0.9% Sodium Chloride Injection, for intravenous use
This release includes forward-looking statements concerning
bivalirudin, including expectations with regard to its anticipated
availability in the U.S. and anticipated benefits associated with its
use. The statements are based on assumptions about many important
factors, including the following, which could cause actual results to
differ materially from those in the forward-looking statements:
satisfaction of regulatory and other requirements; actions of regulatory
bodies and other governmental authorities; product quality,
manufacturing or supply, or patient safety issues; changes in law and
regulations; and other risks identified in Baxter's most recent filing
on Form 10-K and other
BAXTER and GALAXY are trademarks of
Baxter International Inc.