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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
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* :  
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.