Search Orphan Drug Designations and Approvals
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Generic Name: | lanreotide acetate | ||||||||||||||||
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Trade Name: | |||||||||||||||||
Date Designated: | 09/08/2011 | ||||||||||||||||
Orphan Designation: | Treatment of carcinoid syndrome | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Ipsen Biopharmaceuticals, Inc. 106 Allen Road Basking Ridge, New Jersey 07920 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: | lanreotide acetate |
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Trade Name: | ||
Marketing Approval Date: | 09/15/2017 | |
Approved Labeled Indication: | treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy | |
Exclusivity End Date: | 09/15/2024 | |
Exclusivity Protected Indication* : | treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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