FDA approves launch of Baxter's clindamycin injection

DEERFIELD - The U.S. Food and Drug Administration has approved the commercial launch of ready-to-use Baxter International's clindamycin injection in saline in three commonly prescribed formulation.

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," said Robert Felicelli, president, pharmaceuticals at Baxter. "Only Baxter currently offers clindamycin in saline, making this important antibiotic suitable for use with a larger patient population."

Baxter's differentiated pre-mix portfolio is made possible by a unique combination of proprietary technical capabilities in drug formulation, packaging and sterilization. Clindamycin injection in saline will use Baxter's proprietary 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.