Search Orphan Drug Designations and Approvals
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| Generic Name: | crizotinib |
|---|---|
| Trade Name: | Xalkori |
| Date Designated: | 09/13/2010 |
| Orphan Designation: | Treatment of ALK-positive, MET-positive, or ROS-positive non-small cell lung cancer |
| Orphan Designation Status: | Designated/Approved |
| Marketing Approval Date: | 03/11/2016 |
| Approved Labeled Indication: | Treatment of patients with metastatic NSCLC whose tumors are ROS1-positive |
| Exclusivity End Date: | 03/11/2023 |
| Exclusivity Protected Indication* : | Treatment of patients with metastatic NSCLC whose tumors are ROS1-positive |
| Sponsor: |
Pfizer, Inc. 10646 Science Center Drive San Diego, California 92121 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
| Generic Name: | crizotinib |
| Trade Name: | Xalkori |
| Date Designated: | 09/13/2010 |
| Orphan Designation: | Treatment of ALK-positive, MET-positive, or ROS-positive non-small cell lung cancer |
| Orphan Designation Status: | Designated/Approved |
| Marketing Approval Date: | 08/26/2011 |
| Approved Labeled Indication: | Treatment of patients with locally advanced or metastatic non-small cell lungcancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDAapprovedtest |
| Exclusivity End Date: | 08/26/2018 |
| Exclusivity Protected Indication* : | |
| Sponsor: |
Pfizer, Inc. 10646 Science Center Drive San Diego, California 92121 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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