Search Orphan Drug Designations and Approvals
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Generic Name: | entrectinib | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | entrectinib |
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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. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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