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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	sildenafil
Trade Name:	Revatio
Date Designated:	07/28/2011
Orphan Designation:	Treatment of pediatric (defined as children less than 17 years of age) pulmonary arterial hypertension
Orphan Designation Status:	Designated/Approved
Sponsor:	Viatris Specialty LLC 3711 Collins Ferry Road Morgantown, West Virginia 26505 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	sildenafil
	Trade Name:	Revatio
	Marketing Approval Date:	01/31/2023
	Approved Labeled Indication:	treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in pediatric patients 1 to 17 years old to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise
	Exclusivity End Date:	01/31/2030
	Exclusivity Protected Indication* :	treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in pediatric patients 1 to 17 years old to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise

2	Generic Name:	sildenafil
	Trade Name:	Revatio
	Marketing Approval Date:	03/03/2023
	Approved Labeled Indication:	treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in pediatric patients (1 to 17 years old) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise
	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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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