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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208434
Company: HOFFMANN-LA ROCHE

Summary Review

Products on NDA 208434

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALECENSA	ALECTINIB HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208434

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/11/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208434s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208434Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208434Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208434s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208434Orig1s012ltr.pdf
01/29/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208434s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208434Orig1s010ltr.pdf
06/05/2018	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208434s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208434Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208434Orig1s004ltr.pdf
11/06/2017	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208434s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208434Orig1s003ltr.pdf
11/04/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208434s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208434Orig1s001ltr.pdf

Labels for NDA 208434

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208434s012lbl.pdf
01/29/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208434s010lbl.pdf
06/05/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208434s004lbl.pdf
11/06/2017	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208434s003lbl.pdf
11/04/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208434s001lbl.pdf
12/11/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208434s000lbl.pdf

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