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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: cobimetinib
Trade Name:
Date Designated: 01/31/2014
Orphan Designation: Treatment of stage IIb, IIc, III, and IV melanoma with BRAFV600 mutation
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way, MS 241A
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: cobimetinib
Trade Name:
Marketing Approval Date: 11/10/2015
Approved Labeled Indication: For the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation, in combination with vemurafenib. Limitations of Use: COTELLIC is not indicated for treatment of patients with wild-type BRAF melanoma.
Exclusivity End Date: 11/10/2022 
Exclusivity Protected Indication* :  For the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation, in combination with vemurafenib. COTELLIC is not indicated for treatment of patients with wild-type BRAF melanoma
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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