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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ramucirumab
Trade Name: CYRAMZA
Date Designated: 02/16/2012
Orphan Designation: Treatment of gastric cancer
Orphan Designation Status: Designated/Approved
Eli Lilly and Company
33 ImClone Drive
Branchburg, New Jersey 08876
United States

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

Marketing approved:

1 Generic Name: ramucirumab
Trade Name: CYRAMZA
Marketing Approval Date: 04/21/2014
Approved Labeled Indication: CYRAMZA as a single-agent is indicated for the treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
Exclusivity End Date: 04/21/2021 
Exclusivity Protected Indication* :  Treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma, as a single-agent after prior fluoropyrimidine-or platinum-containing therapy.
2 Generic Name: ramucirumab
Trade Name: CYRAMZA
Marketing Approval Date: 11/05/2014
Approved Labeled Indication: Treatment of advanced gastric or gastro-esophageal junction adenocarcinoma, as a single agent or in combination with paclitaxel, after prior fluoropyrimidine- or platinium-containing chemotherapy.
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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