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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: alpelisib
Trade Name: Vijoice
Date Designated: 11/18/2019
Orphan Designation: Treatment of PIK3CA-related overgrowth spectrum
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, New Jersey 07936
United States

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

Marketing approved:

1 Generic Name: alpelisib
Trade Name: Vijoice
Marketing Approval Date: 04/05/2022
Approved Labeled Indication: Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy
Exclusivity End Date: 04/05/2029 
Exclusivity Protected Indication* :  Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy
2 Generic Name: alpelisib
Trade Name: Vijoice
Marketing Approval Date: 04/24/2024
Approved Labeled Indication: treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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