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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Pilocarpine HCl
Trade Name: Salagen
Date Designated: 02/28/1992
Orphan Designation: Treatment of xerostomia and keratoconjunctivitis sicca in Sjogren's syndrome patients.
Orphan Designation Status: Designated/Approved
MGI Pharma, Inc.
5775 West Old Shakoppe Rd.
Suite 100
Bloomington, Minnesota 55437
United States

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

Marketing approved:

1 Generic Name: Pilocarpine HCl
Trade Name: Salagen
Marketing Approval Date: 02/11/1998
Approved Labeled Indication: Treatment of dry mouth in patients with Sjogren's syndrome.
Exclusivity End Date: 02/11/2005 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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