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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: CBDA dominant extract of Cannabis sativa / Low (<0.3% w/w) delta-9-tetrahydrocannabinolic acid (THC-A) and delta 9-tetrahydrocannabinol (THC) extract of Cannabis sativa with major cannabinoid constituent cannabidiolic acid (CBD-A)
Date Designated: 11/25/2024
Orphan Designation: treatment of Rett syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Neurotech International Limited
Suite 5 CPC, 145 Stirling Highway
Nedlands, WA 6009
Australia

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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