ICN Diagnostic Test Is Approved by FDA
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COSTA MESA — ICN Pharmaceuticals Inc. said Tuesday that federal regulators recently approved its diagnostic test for a metabolic disorder in newborns.
The test detects the hereditary disorder galactosemia, which, if left untreated, can cause liver and brain damage, the drug company said. Early diagnosis enables the doctor to prescribe a special diet to reduce harmfully high sugar levels in an infant’s blood.
The federal Food and Drug Administration in November approved the test for marketing. The company did not release news of the approval until yesterday because it was preparing to market the test worldwide, a spokeswoman said.
The test also has been approved for sale in Belgium, Taiwan, Korea and Argentina, she added.
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