LANTIDRA
STN: 125734
Proper Name: donislecel-jujn
Tradename: LANTIDRA
Manufacturer: CellTrans Inc.
Indication:
- the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.
Product Information
- Package Insert - LANTIDRA
- Demographic Subgroup Information – LANTIDRA
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- June 28, 2023 Approval Letter - LANTIDRA
- June 28, 2023 Summary Basis for Regulatory Action - LANTIDRA
- Approval History, Letters, Reviews, and Related Documents - LANTIDRA