Fresenius Kabi Pharmaceuticals (APCVZ)

[profit-seeker]

APP Pharmaceuticals wins FDA approval for generic ductus arteriosus drug
Wednesday 03/24/2010 8:47 AM ET - Datamonitor

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As of 2:08 PM ET 3/24/10

APP Pharmaceuticals, a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, has received the FDA's approval to market indomethacin for injection.

Indomethacin is therapeutically equivalent to the reference-listed drug Indocin IV by Lundbeck. APP will supply indomethacin 1mg as single dose vials. APP's indomethacin is bar-coded, preservative-free and latex-free.

According to APP Pharmaceuticals, indomethacin for injection is used in neonates to treat patent ductus arteriosus, a common congenital heart defect.

APP plans to launch indomethacin for injection in the second quarter of 2010.

John Ducker, president and CEO of APP Pharmaceuticals, said: "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. We are pleased to add this important product to our expanding portfolio of critical care products."