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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
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.

Marketing approved:

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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