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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  glycopyrrolate
Trade Name:  Cuvposa
Date Designated:  06/09/2006
Orphan Designation:  Treatment of pathologic (chronic moderate to severe) drooling in pediatric patients
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  07/28/2010 
Approved Labeled Indication:  To reduce chronic drooling in patients aged 3 - 16 with neurologic conditions associated with problem drooling (e.g. cerebral palsy)
Exclusivity End Date:    07/28/2017 
Exclusivity Protected Indication* :  
Shionogi, Inc.
300 Campus Drive
Florham, New Jersey 07932
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.