Baxter Gains FDA Approval for Sabinanigo Mfg. Facility

Baxter International Inc. received FDA approval for its supplemental drug application to establish its Sabinanigo, Spain, facility as an approved manufacturing site for 0.9% Sodium Chloride Injection, USP, for the U.S. market.
 
The approval includes product presentations in 250 mL, 500 mL and 1000 mL, which Baxter has been distributing in the U.S. to alleviate a drug shortage with the knowledge of the FDA. These three product presentations of 0.9% Sodium Chloride Injection, USP, known as saline, have been in short supply the past two years.
 
“The approval of an additional manufacturing site for Sodium Chloride Injection in the U.S. gives us greater flexibility to respond to market demand fluctuations and will help as we continue to meet patient and healthcare provider need for this critical product,” said Brik Eyre, president of Baxter’s Hospital Products business. “FDA was quick to recognize the benefit of addressing industry demand for sterile IV solutions in collaboration with companies like Baxter.”