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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  nimodipine
Trade Name:  NYMALIZE
Date Designated:  09/16/2011
Orphan Designation:  Treatment of subarachnoid hemorrhage.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  05/10/2013 
Approved Labeled Indication:  Improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).
Exclusivity End Date:    05/10/2020 
Exclusivity Protected Indication* :  Improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).
Arbor Pharmaceuticals, Inc.
6 Concourse Parkway
Suite 1800
Atlanta, Georgia 30328
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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