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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217513
Company: NOVARTIS

Products on NDA 217513

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEKINIST	TRAMETINIB DIMETHYL SULFOXIDE	EQ 0.05MG BASE/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes
MEKINIST	TRAMETINIB	2MG	TABLET;ORAL	Prescription	None	No	No
MEKINIST	TRAMETINIB	4.7MG	SOLUTION;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217513

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2023	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217513s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217513Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217513Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2026	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217513s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/204114Orig1s040,217513Orig1s011ltr.pdf
01/24/2025	SUPPL-10	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204114Orig1s036;217513Orig1s010correctedltr.pdf
04/07/2025	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204114s038,217513s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204114Orig1s038_217513Orig1s009ltr.pdf
03/19/2025	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204114s037,217513s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204114Orig1s037; 217513Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204114Orig1s037; 217513Orig1s008ltr.pdf
10/01/2024	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s027,217513s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204114Orig1s027, 217513Orig1s007correctedltr.pdf
03/07/2025	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204114Orig1s034; 217513Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204114Orig1s034,217513Orig1s005ltr.pdf
07/11/2024	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s033,217513s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204114Orig1s033;217513Orig1s004ltr.pdf
03/29/2024	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217513s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217513Orig1s003ltr.pdf
02/27/2024	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s031,217513s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204114Orig1s031; 217513Orig1s002ltr.pdf

Labels for NDA 217513

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/26/2026	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217513s011lbl.pdf
04/07/2025	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204114s038,217513s009lbl.pdf
03/19/2025	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204114s037,217513s008lbl.pdf
03/07/2025	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204114Orig1s034; 217513Orig1s005lbl.pdf
10/01/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s027,217513s007lbl.pdf
07/11/2024	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s033,217513s004lbl.pdf
03/29/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217513s003lbl.pdf
02/27/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s031,217513s002lbl.pdf
03/16/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217513s000lbl.pdf

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