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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Sterile talc powder
Trade Name: Sclerosol Intrapleural Aerosol
Date Designated: 09/18/1995
Orphan Designation: Treatment of malignant pleural effusion.
Orphan Designation Status: Designated/Approved
Sciarra Laboratories, Inc.
485-09 South Broadway
Hicksville, New York 11801
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Sterile talc powder
Trade Name: Sclerosol Intrapleural Aerosol
Marketing Approval Date: 12/24/1997
Approved Labeled Indication: Prevention of recurrence of malignant pleural effusions in symptomatic patients.
Exclusivity End Date: 12/24/2004 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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