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news.APP Pharmaceuticals, a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals, has received FDA approval to market Indomethacin for injection.
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Indomethacin is therapeutically equivalent to the reference-listed drug Indocin IV, by Lundbeck. The company is planning to launch Indomethacin for injection in the second quarter of 2010.
APP Pharma will supply Indomethacin 1mg as single dose vials. APP’s Indomethacin is bar-coded, preservative-free and latex-free.
Indomethacin for injection is used in neonates to treat patent ductus arteriosus (PDA). It is indicated to close a hemodynamically patent ductus arteriosus in premature infants weighing between 500g and 1,750g, and is used after 48 hours when the usual medical management (eg, fluid restriction, diuretics, digitalis, respiratory support, etc) has become ineffective.
John Ducker, president and CEO of APP Pharma, said: “This approval demonstrates APP’s continuing commitment to providing products for specialised 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.”