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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214103
Company: ALNYLAM PHARMS INC

Products on NDA 214103

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXLUMO	LUMASIRAN SODIUM	EQ 94.5MG BASE/0.5ML (EQ 94.5MG BASE/0.5ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214103

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214103Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214103Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/19/2023	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214103s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214103Orig1s004ltr.pdf
10/06/2022	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214103s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214103Orig1s003ltr.pdf

Labels for NDA 214103

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/19/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214103s004lbl.pdf
10/06/2022	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214103s003lbl.pdf
11/23/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214103lbl.pdf

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