Search Orphan Drug Designations and Approvals
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Generic Name: | Felbamate | ||||||||||||||||
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Trade Name: | Felbatol | ||||||||||||||||
Date Designated: | 01/24/1989 | ||||||||||||||||
Orphan Designation: | Treatment of Lennox-Gastaut syndrome. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Wallace Laboratories 301B College Road East Princeton, New Jersey 08540 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: | Felbamate |
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Trade Name: | Felbatol | |
Marketing Approval Date: | 07/29/1993 | |
Approved Labeled Indication: | As adjunctive therapy in the treatment of partial and generalized seizures associated with the Lennox-Gastaut syndrome in children. | |
Exclusivity End Date: | 07/29/2000 | |
Exclusivity Protected Indication* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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