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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
Shionogi, Inc.
300 Campus Drive
Florham, New Jersey 07932
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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