Malignant Pleural Effusion

FDA grants approval of Sterile Talc Powder

Published in Medical Letter on the CDC and FDA, January 18th, 2004

Bryan Corporation, an initiate for chemical pleurodesis solutions, announced that the U.S. Food and Drug Administration (FDA) approved its product, Sterile Talc Powder (5 g, 100 ml vial), NDC 63256-200-04, administered intrapleurally via chest tube, as a sclerosing agent to decrease the recurrence of malignant pleural effusions in symptomatic patients.

Sterile Talc Powder is a natural, asbestos-free product, supplied sterile in a single use 100 ml amber glass vial. The recommended dose is 5 g, dissolved in 50-100 ml sodium chloride administered slowly through the chest tube. Each 5 g dosage is sterilized via gamma irradiation and is of a controlled particle size.

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Source: Medical Letter on the CDC and FDA (2004-01-18)

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