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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	pralsetinib
Trade Name:	Gavreto
Date Designated:	05/26/2020
Orphan Designation:	Treatment of RET-fusion, RET-mutation, and TRKC-positive poorly differentiated thyroid cancer, undifferentiated or anaplastic thyroid cancer, medullary thyroid cancer, and locally advanced or metastatic follicular or papillary thyroid cancer
Orphan Designation Status:	Designated/Approved
Sponsor:	Genentech, Inc. 1 DNA Way South San Francisco, California 94080-4990 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	pralsetinib
	Trade Name:	Gavreto
	Marketing Approval Date:	12/01/2020
	Approved Labeled Indication:	Treatment of (1) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy; and; (2) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
	Exclusivity End Date:	12/01/2027
	Exclusivity Protected Indication* :	Treatment of (1) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy; and; (2) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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