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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 (intranasal)
Trade Name:  VALTOCO
Date Designated:  11/16/2015
Orphan Designation:  Management of acute repetitive seizures
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  01/10/2020 
Approved Labeled Indication:  Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.
Exclusivity End Date:    01/10/2027 
Exclusivity Protected Indication* :  Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.
Neurelis Pharmaceuticals, Inc.
11682 El Camino Reall
Suite 255
San Diego, California 92130
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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