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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Pentosan polysulfate sodium
Trade Name: Elmiron
Date Designated: 08/07/1985
Orphan Designation: Treatment of interstitial cystitis.
Orphan Designation Status: Designated/Approved
Alza Corporation
950 Page Mill Rd.
PO Box 10950
Palo Alto, California 94303
United States

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

Marketing approved:

1 Generic Name: Pentosan polysulfate sodium
Trade Name: Elmiron
Marketing Approval Date: 09/26/1996
Approved Labeled Indication: Relief of bladder pain or discomfort associated with interstitial cystitis.
Exclusivity End Date: 09/26/2003 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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