A Baxter International ($BAX) plant in Spain which has been drafted to help alleviate a shortage of saline in the U.S. has gotten a new FDA designation that gives it more flexibility.
The drugmaker said Friday that the FDA had approved the company's supplemental drug application for its plant in Sabinanigo, Spain, to produce 0.9% sodium chloride injection. The plant had been granted a temporary special importation permission from the FDA in April 2014, a designation that carried more requirements than the drug approval. Baxter has been shipping 250-mL, 500-mL and 1000-mL presentations of saline from the plant to help relieve the shortage that has persisted for more than 18 months.
"The approval of an additional manufacturing site for sodium chloride injection in the U.S. gives us greater flexibility to respond to market demand fluctuations and will help as we continue to meet patient and healthcare provider need for this critical product," Brik Eyre, president of Baxter's Hospital Products business, said in a statement.
The FDA had been working with Baxter, Hospira ($HSP) and B. Braun Medical to boost their U.S. production but, as the shortage persisted, started allowing the import of product from some plants in Europe that were not previously approved for U.S. distribution. In addition to Baxter's Spanish plant, it has given temporary permission to a Fresenius Kabi plant in Norway and more recently, for a B. Braun plant in Germany.
But even as it has broadened the sources of saline, manufacturing problems have led to recalls, which has kept the U.S. supply chain from getting fully replenished. In April, Baxter had voluntarily recalled three lots of 0.9% sodium chloride injection amounting to nearly 600,000 units because of leaky bags. Several weeks later it recalled another 8 lots after particulate was found in some bags. Hospira voluntarily recalled two dozen lots of saline solution in the 1000-mL size last fall because of issues with leaking bags.
- here's the announcement