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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
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.

Marketing approved:

1 Generic Name: nimodipine
Trade Name: NYMALIZE
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).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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