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Two hundred and fifty-five neonates, infants and children, from 45 hospitals, who were receiving chloramphenicol therapy for serious infections were the subject of this study. Samples of serum and cerebrospinal fluid CSF were assayed for chloramphenicol and the patient's treatment regimens analysed. In older children the recommended dose was used. Thirty-one percent of neonates and infants had potentially toxic serum concentrations. Concomitant administration of phenobarbitone or phenytoin had no effect on mean serum chloramphenicol levels. Serum concentrations of chloramphenicol were significantly higher in patients also receiving penicillin.

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The President of the United States manages the operations of the Executive branch of Government through Executive orders. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. Armenpharm, 49 South Ridge Rd. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application NDA. However, on March 17, Armenpharm withdrew its oral hearing request. FDA has become aware that the oral chloramphenicol drug products listed in the table in this document are no longer being marketed.

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