The US Food and Drug Administration (FDA) has approved Baxter International's supplemental drug application to establish its Sabinanigo, Spain, facility as an approved manufacturing site for 0.9% sodium chloride injection, USP, for the US market.
The approval includes product presentations in 250 mL, 500 mL and 1000 mL, which Baxter has been distributing in the US 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 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,'' 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. This approval illustrates the strength of Baxter's global manufacturing network, as well as our commitment to meeting important healthcare needs.''
Intravenous (IV) and other sterile solutions are critical to treatment in a health care setting. These solutions have a wide range of applications which include regulation of blood pressure, hydration, electrolyte balance, medication and nutrition delivery, flushing, clearing out IV lines and feed tubes, wound cleaning, renal dialysis and in plasma collection. According to the US Centers for Disease Control and Prevention, there were more than 50 million surgeries in the United States in 2010. Baxter estimates that some of these surgeries, such as urological and gynaecological surgeries, and knee and hip replacements, may require up to 30 liters of solution for each procedure.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions.