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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: necitumumab
Trade Name:
Date Designated: 11/20/2015
Orphan Designation: Treatment of squamous non-small cell lung 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: necitumumab
Trade Name:
Marketing Approval Date: 11/24/2015
Approved Labeled Indication: Use in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic, squamous, non-small cell lung cancer. Limitation of Use: PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer.
Exclusivity End Date: 11/24/2022 
Exclusivity Protected Indication* :  Use in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic, squamous, non-small cell lung cancer. PORTRAZZA is not indicated for treatment of non-squamous, non-small cell lung cancer
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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