Search Orphan Drug Designations and Approvals
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| Generic Name: | imatinib |
|---|---|
| Trade Name: | Gleevec |
| Date Designated: | 10/11/2005 |
| Orphan Designation: | Treatment of Philadelphia-positive acute lymphoblastic leukemia |
| Orphan Designation Status: | Designated/Approved |
| Marketing Approval Date: | 10/19/2006 |
| Approved Labeled Indication: | Treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) |
| Exclusivity End Date: | 10/19/2013 |
| Exclusivity Protected Indication* : | |
| Sponsor: |
Novartis Pharmaceuticals Corporation One Health Plaza Mail Code 105/1E870D East Hanover, New Jersey 07936 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
| Generic Name: | imatinib |
| Trade Name: | Gleevec |
| Date Designated: | 10/11/2005 |
| Orphan Designation: | Treatment of Philadelphia-positive acute lymphoblastic leukemia |
| Orphan Designation Status: | Designated/Approved |
| Marketing Approval Date: | 01/25/2013 |
| Approved Labeled Indication: | Pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy |
| Exclusivity End Date: | 01/25/2020 |
| Exclusivity Protected Indication* : | Treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy |
| Sponsor: |
Novartis Pharmaceuticals Corporation One Health Plaza Mail Code 105/1E870D East Hanover, New Jersey 07936 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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