COTELLIC از شرکت GENENTECH INC

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

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

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
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-Patient Package Insert, Labeling-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

Action Date

Submission

Supplement Categories or Approval Type

Letters, Reviews, Labels, Patient Package Insert

Note

Url

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-Patient Package Insert, Labeling-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	Url
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-Patient Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206192s001lbl.pdf
05/31/2016	SUPPL-1	Labeling-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

منبع : www.accessdata.fda.gov

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COTELLIC از شرکت GENENTECH INC