Search Orphan Drug Designations and Approvals
-
Generic Name: | Dasatinib | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Trade Name: | Sprycel | ||||||||||||||||
Date Designated: | 11/18/2005 | ||||||||||||||||
Orphan Designation: | Treatment of Philadelphia-positive acute lymphoblastic leukemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Bristol-Myers Squibb Company P. O Box 5326 Mailstop C 4065 Princeton, New Jersey 08542 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
||||||||||||||||
Marketing approved: |
|||||||||||||||||
1 | Generic Name: | Dasatinib |
---|---|---|
Trade Name: | Sprycel | |
Marketing Approval Date: | 06/28/2006 | |
Approved Labeled Indication: | Treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy | |
Exclusivity End Date: | 06/28/2013 | |
Exclusivity Protected Indication* : | ||
2 | Generic Name: | Dasatinib |
---|---|---|
Trade Name: | Sprycel | |
Marketing Approval Date: | 12/21/2018 | |
Approved Labeled Indication: | SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. | |
Exclusivity End Date: | 12/21/2025 | |
Exclusivity Protected Indication* : | SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-