WOBURN, Mass., Dec. 16 /PRNewswire/ -- Bryan Corporation, an initiate for chemical pleurodesis solutions, today announced that the U.S. Food and Drug Administration approved its product, Sterile Talc Powder (5 g, 100 ml vial), NDC 63256-200-04, 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, which will be available immediately, 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.
ABOUT BRYAN CORPORATION
Bryan Corporation is a Woburn, MA, based company, devoted, since its founding in 1979, to providing health care professionals with unique, high quality medical devices and innovative pharmaceuticals. For more information on Bryan Corporation, please visit our Web site at http://www.bryancorp.com/.
4 Plympton Street
Woburn, MA 01801