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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206192
Company: GENENTECH INC

Summary Review

Products on NDA 206192

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COTELLIC	COBIMETINIB FUMARATE	EQ 20MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206192

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206192s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206192Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206192Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206192Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206192s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206192Orig1s006ltr.pdf
10/28/2022	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206192s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206192Orig1s005ltr.pdf
07/28/2022	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206192s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206192Orig1s004ltr.pdf
01/26/2018	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206192s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206192Orig1s002ltr.pdf
05/31/2016	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206192s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206192Orig1s001ltr.pdf

Labels for NDA 206192

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206192s006lbl.pdf
10/28/2022	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206192s005lbl.pdf
07/28/2022	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206192s004lbl.pdf
01/26/2018	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206192s002lbl.pdf
05/31/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206192s001lbl.pdf
05/31/2016	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206192s001lbl.pdf
11/10/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206192s000lbl.pdf

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