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news.The US Food and Drug Administration (FDA) has granted approval for Baxter International's supplemental drug application to establish its Sabinanigo facility in Spain, as an approved manufacturing site for 0.9% Sodium Chloride Injection, USP, to be sold in the US market.
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The company said that additional site approval comes amid increased industry demand for sterile Intravenous (IV) solutions
The approval includes product presentations in 250mL, 500mL and 1000mL, which the company has been distributing in the US to alleviate a drug shortage.
All these product presentations of 0.9% Sodium Chloride Injection, USP, more commonly called 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.
Baxter Hospital Products business president Brik Eyre said: "The approval of an additional manufacturing site for Sodium Chloride Injection in the US 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.
"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."
Image: The FDA approval is for Baxter’s 250mL, 500mL and 1000mL presentations of 0.9% Sodium Chloride Injection, USP, for the US market. Photo: courtesy of Baitong333/ freedigitalphotos.net.