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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214998
Company: BRISTOL

Medication Guide

REMS

Products on NDA 214998

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAMZYOS	MAVACAMTEN	2.5MG	CAPSULE;ORAL	Prescription	None	Yes	No
CAMZYOS	MAVACAMTEN	5MG	CAPSULE;ORAL	Prescription	None	Yes	Yes
CAMZYOS	MAVACAMTEN	10MG	CAPSULE;ORAL	Prescription	None	Yes	No
CAMZYOS	MAVACAMTEN	15MG	CAPSULE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214998

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2022	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214998s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214998Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214998Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2024	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214998s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214998Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214998Orig1s009ltr.pdf
12/19/2023	SUPPL-8	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214998Orig1s008ltr.pdf
01/13/2023	SUPPL-4	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214998Orig1s004ltr.pdf
11/22/2022	SUPPL-3	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214998Orig1s003ltr.pdf
06/15/2023	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214998s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214998Orig1s001ltr.pdf

Labels for NDA 214998

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2024	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214998s009lbl.pdf
06/15/2023	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214998s001lbl.pdf
04/28/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214998s000lbl.pdf

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