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Tuesday, 12/26/2017 9:45:06 AM

Tuesday, December 26, 2017 9:45:06 AM

Post# of 581
APTO

Search Orphan Drug Designations and Approvals
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FDA HomeDeveloping Products for Rare Diseases & Conditions
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Generic Name: 1-{3-fluoro-4-[7-(5-methyl-lH-imidazol-2-yl)- 1-oxo-2,3-dihydro-lH-isoindo 1-4-yl]-phenyl}-3-(3-trifluoromethyl-phenyl)-urea
Trade Name: N/A
Date Designated: 12/22/2017
Orphan Designation: Treatment of acute myeloid leukemia (AML)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marketing Approval Date: N/A
Approved Labeled Indication:
Exclusivity End Date: N/A
Sponsor: Aptose Biosciences, Inc.
12770 High Bluff Drive
Suite 120
San Diego, California 92130
USA
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