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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211710
Company: BAYER HEALTHCARE

Products on NDA 211710

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VITRAKVI	LAROTRECTINIB SULFATE	EQ 20MG BASE/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211710

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 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211710s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211710Orig1s000ltr.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-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211710s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211710Orig1s010ltr.pdf
11/03/2023	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211710s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211710Orig1s009ltr.pdf
11/23/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211710s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211710Orig1s008ltr.pdf
03/25/2021	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211710s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211710Orig1s005ltr.pdf
03/25/2021	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211710s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211710Orig1s004ltr.pdf

Labels for NDA 211710

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2025	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211710s010lbl.pdf
11/03/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211710s009lbl.pdf
11/23/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211710s008lbl.pdf
03/25/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211710s005lbl.pdf
03/25/2021	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211710s004lbl.pdf
11/26/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211710s000lbl.pdf

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