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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
Trade Name: Steritalc
Date Designated: 12/08/1997
Orphan Designation: Treatment of pneumothorax
Orphan Designation Status: Designated/Approved
Novatech SA
Z.I. Athelia III
La Ciotat , CEDEX
France

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

Marketing approved:

1 Generic Name: Sterile talc
Trade Name: Steritalc
Marketing Approval Date: 05/01/2017
Approved Labeled Indication: Steritalc is indicated in adults to decrease the recurrence of pneumothorax.
Exclusivity End Date: 05/01/2024 
Exclusivity Protected Indication* :  To decrease the recurrence of pneumothorax in adults.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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