APP Pharmaceuticals has announced U.S. Food and Drug Administration (FDA) approval for Levothyroxine Sodium for Injection, which is used to treat myxedema coma, a complication of hypothyroidism. It will be marketed in 100 mcg, 200 mcg and 500 mcg single dose vials
“APP worked closely with the FDA to secure approval of Levothyroxine Sodium for Injection because of the expressed medical need for this drug,” said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. “We will continue to collaborate with the FDA to gain approval of established and much needed drugs that maintain the highest standards of quality, safety and efficacy.”
APP Pharmaceuticals intend on launching further products in the line of Levothyroxine Sodium for Injection over the coming months. Recent data from IMS indicated the market for Levothyroxine Sodium for Injection was $26.9 million, with 939,000 units sold.