FDA News

FDA approves ready-to-use version of bivalirudin for PCI

Baxter International Inc. announced the FDA approved its ready-to-use version of bivalirudin as an anticoagulant in patients undergoing PCI.

According to a press release from the company, its version of the direct thrombin inhibitor bivalirudin (Bivalirudin in 0.9 percent Sodium Chloride Injection) will use a non-PVC and non-DEHP system (Galaxy container technology) designed to create a ready-to-use format for unstable molecules.

Premixed versions of commonly prescribed drugs help simplify the preparation process and may avoid potential errors that may occur as a result of compounding, the company stated in the release.

Baxter’s bivalirudin is expected to launch in the United States in early 2018 in two dosage forms: 250 mg per 50 mL and 500 mg per 100 mL, according to the release.

“The approval of bivalirudin demonstrates how Baxter brings its innovative technologies together with medicines in ways that help promote efficiency for clinicians,” Robert Felicelli, president of pharmaceuticals at Baxter, said in the release. “Baxter’s presentation of this widely used cardiovascular medication is the first and only available in a convenient frozen premixed solution.”

Disclosure: Felicelli is an employee of Baxter.

 

Baxter International Inc. announced the FDA approved its ready-to-use version of bivalirudin as an anticoagulant in patients undergoing PCI.

According to a press release from the company, its version of the direct thrombin inhibitor bivalirudin (Bivalirudin in 0.9 percent Sodium Chloride Injection) will use a non-PVC and non-DEHP system (Galaxy container technology) designed to create a ready-to-use format for unstable molecules.

Premixed versions of commonly prescribed drugs help simplify the preparation process and may avoid potential errors that may occur as a result of compounding, the company stated in the release.

Baxter’s bivalirudin is expected to launch in the United States in early 2018 in two dosage forms: 250 mg per 50 mL and 500 mg per 100 mL, according to the release.

“The approval of bivalirudin demonstrates how Baxter brings its innovative technologies together with medicines in ways that help promote efficiency for clinicians,” Robert Felicelli, president of pharmaceuticals at Baxter, said in the release. “Baxter’s presentation of this widely used cardiovascular medication is the first and only available in a convenient frozen premixed solution.”

Disclosure: Felicelli is an employee of Baxter.