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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210861
Company: BAYER HLTHCARE

Products on NDA 210861

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VITRAKVI	LAROTRECTINIB SULFATE	EQ 25MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
VITRAKVI	LAROTRECTINIB SULFATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210861

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210861s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210861Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210861Orig1s000_21171Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2025	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210861s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210861Orig1s012ltr.pdf
11/03/2023	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210861s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210861Orig1s010ltr.pdf
11/23/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210861s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210861Orig1s008ltr.pdf
03/25/2021	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210861s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210861Orig1s006ltr.pdf
03/25/2021	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210861Orig1s004ltr.pdf

Labels for NDA 210861

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2025	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210861s012lbl.pdf
11/03/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210861s010lbl.pdf
11/03/2023	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210861s010lbl.pdf
11/23/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210861s008lbl.pdf
03/25/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210861s006lbl.pdf
11/26/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210861s000lbl.pdf

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