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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: Cotellic
Date Designated: 04/26/2021
Orphan Designation: Treatment for histiocytic neoplasms
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way MS#451b
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: Cotellic
Marketing Approval Date: 10/28/2022
Approved Labeled Indication: as a single agent for the treatment of adult patients with histiocytic neoplasms
Exclusivity End Date: 10/28/2029 
Exclusivity Protected Indication* :  treatment of adult patients with histiocytic neoplasms
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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