APP receives FDA approval to market Clonidine Hydrochloride 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) to market Clonidine Hydrochloride Injection in two dosage strengths. Clonidine Hydrochloride Injection is therapeutically equivalent to the reference-listed drug Duraclon®, currently marketed by the innovator Astellas U.S. Holding, Inc. (formerly Yamanouchi U.S. Holding Inc.).

APP will launch Clonidine Hydrochloride Injection immediately and market the analgesic in 1000 mcg/10 ml and 5000 mcg/10 ml single dose vials. APP's Clonidine Hydrochloride Injection is AP-rated, preservative-free and bar-coded. According to IMS data, 2010 product sales in the United States were approximately $3.13 million.

"The approval of APP's Clonidine Hydrochloride further strengthens the company's analgesic portfolio of products and helps solidify our continued leadership as a leading generic injectable company," said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals.