Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219083
Company: CYTOKINETICS

Products on NDA 219083

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYQORZO	AFICAMTEN	5MG	TABLET;ORAL	Prescription	None	Yes	Yes
MYQORZO	AFICAMTEN	10MG	TABLET;ORAL	Prescription	None	Yes	No
MYQORZO	AFICAMTEN	15MG	TABLET;ORAL	Prescription	None	Yes	No
MYQORZO	AFICAMTEN	20MG	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219083

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2025	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219083s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219083Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/219083Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2026	SUPPL-1	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219083Orig1s001ltr.pdf

Labels for NDA 219083

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219083s000lbl.pdf