Search Orphan Drug Designations and Approvals
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Generic Name: | sofosbuvir and velpatasvir | ||||||||||||||||
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Trade Name: | Epclusa | ||||||||||||||||
Date Designated: | 02/22/2017 | ||||||||||||||||
Orphan Designation: | Treatment of pediatric chronic hepatitis C virus (HCV) infection | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Gilead Sciences, Inc. 333 Lakeside Drive Foster City, California 94404 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | sofosbuvir and velpatasvir |
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Trade Name: | Epclusa | |
Marketing Approval Date: | 03/19/2020 | |
Approved Labeled Indication: | EPCLUSA is indicated for the treatment of adults and pediatric patients 6 years of age and older or weighing at least 17 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin. | |
Exclusivity End Date: | 03/19/2027 | |
Exclusivity Protected Indication* : | For the treatment of pediatric patients 6 years of age and older or weighing at least 17 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin. | |
2 | Generic Name: | sofosbuvir and velpatasvir |
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Trade Name: | Epclusa | |
Marketing Approval Date: | 06/10/2021 | |
Approved Labeled Indication: | treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis for use in combination with ribavirin | |
Exclusivity End Date: | 06/10/2028 | |
Exclusivity Protected Indication* : | treatment of pediatric patients 3 years of age to less than 6 years of age weighing less than 17 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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