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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: entrectinib
Trade Name: ROZLYTREK
Date Designated: 02/03/2015
Orphan Designation: Treatment of TrkA-positive, TrkB-positive, TrkC-positive ROS1-positive or ALK-positive non-small cell lung cancer
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: entrectinib
Trade Name: ROZLYTREK
Marketing Approval Date: 08/15/2019
Approved Labeled Indication: ROZLYTREK is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.
Exclusivity End Date: 08/15/2026 
Exclusivity Protected Indication* :  For the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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