Sterile Talc Powder
Drug class: Miscellaneous uncategorized agents
Approval date: December 15, 2003
Company: Bryan Corporation
Treatment for: Malignant Pleural Effusion
Medically reviewed by Drugs.com. Last updated on May 31, 2022.
Sterile Talc Powder Approved by FDA
The U.S. Food and Drug Administration has approved Sterile Talc Powder (5 g, 100 ml vial) administered intrapleurally via chest tube, as sclerosing agent to decrease the recurrence of malignant pleural effusions in symptomatic patients.
Sterile Talc Powder (Product #1690), 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.
This product, joins the only other licensed form of talc, Sclerosol Intrapleural Aerosol, also manufactured and marketed by Bryan Corporation. Sclerosol Intrapleural Aerosol is packaged with a chlorofluorocarbon (CFC) propellant for direct insufflation into the pleural cavity intraoperatively or during thoracoscopy. Both of these talc products are made exclusively by Bryan Corporation, and are covered by an Orphan Drug designation held by Bryan Corporation.
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