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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  diazepam auto-injector
Date Designated:  05/30/2013
Orphan Designation:  Management of selected, refractory patients with epilepsy on stable regimens of antiepileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Meridian Medical Technologies, Inc.
6350 Stevens Forest Rd, Suite 301
Columbia, Maryland 21046
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.