Baxter Reports FDA Approval, Launch of Clindamycin Injection in Saline

The FDA has approved clindamycin injection in saline (Baxter) in 3 commonly-prescribed formulations (300mg/50mL, 600mg/50mL, 900mg/50mL). Officials with Baxter made the press announcement about the commercial launch at the American Society of Health-System Pharmacists (ASHP) Summer Meetings, taking place this week in Minneapolis.¹

Clindamycin injection in saline will use Baxter’s GALAXY container technology, a non-PVC and non-DEHP system that enables premixed medicines to have a longer shelf life when stored at room temperature. Using premixed versions of standard doses of commonly prescribed drugs can help enhance patient safety by eliminating potential dosing errors that may occur when medications are compounded, a process that combines different drug agents in specific quantities to fill individualized prescriptions to meet a patient’s needs.

Clindamycin in saline is the third premix from Baxter to receive FDA approval since August 2015.

Clindamycin is a lincosamide antibacterial indicated for the treatment of the following:

• Serious infections caused by susceptible anaerobic bacteria.
• Infections Due to susceptible Strains of Streptococci, pneumococci and Staphylococci.
• Lower Respiratory Tract Infections.
• Skin and Skin Structure Infections.
• Gynecological Infections.
• Intra-abdominal Infections.
• Septicemia.
• Bone and Joint Infections.

Since clindamycin does not diffuse adequately into the cerebrospinal fluid, Clindamycin in 0.9% Sodium Chloride Injection should not be used in the treatment of meningitis.

Clindamycin is a widely-prescribed antibiotic for serious infections caused by susceptible anaerobic bacteria and strains of streptococci, pneumococci and staphylococci when penicillin is inappropriate for a patient. For clinicians, clindamycin injection in saline provides an alternative to administer to patients for whom the use of dextrose is contraindicated or undesirable. Baxter’s ready-to-use clindamycin injection in saline is now available to customers in the United States.

“The addition of clindamycin to Baxter’s portfolio of ready-to-use premixed medicines reinforces the company’s commitment to hospital pharmacies and to be a leader in the generic injectable pharmaceuticals space by providing high-quality, essential medicines that will benefit patients worldwide,” Robert Felicelli, president of pharmaceuticals, Baxter said in the release. “Only Baxter currently offers clindamycin in saline, making this important antibiotic suitable for use with a larger patient population.”

Reference

Baxter Announces U.S. FDA Approval and Commercial Launch of Ready-To-Use Clindamycin Injection in Saline [news release]. Deerfield Ill.. Accessed at: https://www.baxter.com/news-media/newsroom/press-releases/2017/06-07-17-clinda-saline-approval-and-launch.page