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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214662
Company: MIRUM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIVMARLI MARALIXIBAT CHLORIDE EQ 9.5MG BASE/ML SOLUTION;ORAL Prescription None Yes Yes
LIVMARLI MARALIXIBAT CHLORIDE EQ 19MG BASE/ML SOLUTION;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/29/2021 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214662s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214662Orig1s000Corrected_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214662Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2024 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214662Orig1s011ltr.pdf
07/24/2024 SUPPL-10 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214662Orig1s009,s010ltr.pdf
07/24/2024 SUPPL-9 Manufacturing (CMC)-New Strength Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214662Orig1s009,s010ltr.pdf
03/13/2024 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214662Orig1s005,s008ltr.pdf
03/13/2024 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s005s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214662Orig1s005,s008ltr.pdf
03/13/2023 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214662s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214662Orig1s004ltr.pdf
04/01/2022 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214662s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214662Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/08/2024 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s011lbl.pdf
07/24/2024 SUPPL-10 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s009s010lbl.pdf
07/24/2024 SUPPL-9 Manufacturing (CMC)-New Strength Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s009s010lbl.pdf
03/13/2024 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s005s008lbl.pdf
03/13/2024 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214662s005s008lbl.pdf
03/13/2023 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214662s004lbl.pdf
04/01/2022 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214662s001lbl.pdf
09/29/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214662s000lbl.pdf
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