aaiPharma Inc announced the launch and first commercial sale of Calcitriol Injection, a liquid, injectable vitamin D product used primarily to treat chronic kidney dialysis patients with abnormally low levels of calcium in the circulating blood, and the first line extension to its family of critical care nutrition products.
On February 20, 2003, aaiPharma announced that the U.S. Food and Drug Administration (FDA) had granted marketing approval for Calcitriol Injection. With this approval, the FDA also granted the Company "shared market exclusivity." According to the terms of the shared exclusivity, the 180-day exclusivity time period starts upon the first commercial sale of Calcitriol by either of the companies sharing exclusivity. aaiPharma believes that, with its launch, it is the first company of the two companies to enter the market.
"We are very pleased to make our Calcitriol Injection product, packaged in a unique vial format, commercially available," said Dr. Philip Tabbiner, President and Chief Executive Officer of aaiPharma. "This launch is an exciting milestone for aaiPharma."