APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., has received approval from the FDA to market Indomethacin for Injection. Indomethacin is therapeutically equivalent to the reference-listed drug INDOCIN I.V., by Lundbeck, Inc.
APP will supply Indomethacin 1 mg as single dose vials. APP's Indomethacin is bar-coded, preservative-free and latex-free. According to IMS data, 2009 sales of this product in the United States were approximately $22.5 million.
Indomethacin for Injection is used in neonates to treat patent ductus arteriosus (PDA), a common congenital heart defect. It is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 grams and 1,750 grams, and is used after 48 hours when the usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) has become ineffective.
"This approval demonstrates APP's continuing commitment to providing products for specialized patient populations, including our country's fragile neonates, who are among the most vulnerable of patients," said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. " We are pleased to add this important product to our expanding portfolio of critical care products."
APP plans to launch Indomethacin for Injection in the second quarter of 2010.