APP Pharmaceuticals Announces Approval of Levothyroxine Sodium for Injection

-APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for Levothyroxine Sodium for Injection. Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma, a life-threatening complication of hypothyroidism.
As the sole manufacturer of Levothyroxine Sodium for Injection, APP Pharmaceuticals will be introducing an extension of its current product line in the next several months. In 2010, IMS Data indicated the market size for Levothyroxine Sodium for Injection was $26.9 million with 939,000 units of all strengths sold.“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' Levothyroxine Sodium for Injection will be marketed in single dose 100 mcg, 200 mcg, and 500 mcg vials.