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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Apomorphine
Date Designated: 07/17/1995
Orphan Designation: Treatment of the on-off fluctuations associated with late-stage Parkinson's disease.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pentech Pharmaceuticals, Inc.
1110 Lake Cook Rd.
Suite 257
Buffalo Grove, Illinois 60089
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.
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