Baxter International Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved the company's 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. All three of these product presentations of 0.9% Sodium Chloride Injection, USP, more commonly known as saline, have been listed in drug shortage databases maintained by FDA and the American Society of Health-System Pharmacists over 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.
Eyre continued, "FDA was quick to recognize the benefit of addressing industry demand for sterile IV solutions in collaboration with companies like Baxter. This approval illustrates the strength of Baxter's global manufacturing network, as well as our commitment to meeting important healthcare needs."