An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
04/18/2024	SUPPL-15	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208434s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208434Orig1s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/208434Orig1s015MultidisciplineR.pdf
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
04/18/2024	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208434s015lbl.pdf
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

Top