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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
Trade Name: Salagen
Date Designated: 09/24/1990
Orphan Designation: Treatment of xerostomia induced by radiation therapy for head and neck cancer.
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
Trade Name: Salagen
Marketing Approval Date: 03/22/1994
Approved Labeled Indication: Treatment of symptoms of xerostomia from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck.
Exclusivity End Date: 03/22/2001 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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