COSENTYX از شرکت NOVARTIS PHARMS CORP

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

Biologic License Application (BLA): 125504

Company: NOVARTIS PHARMS CORP

Medication Guide

Summary Review

Products on BLA 125504

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COSENTYX	SECUKINUMAB	150MG/ML	INJECTABLE;INJECTION	Prescription	TBD	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125504

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/2015	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125504Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000SumR.pdf

Action Date

Submission

Action Type

Submission Classification

Review Priority; Orphan Status

Letters, Reviews, Labels, Patient Package Insert

Notes

Url

01/21/2015

ORIG-1

Approval

N/A

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125504Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000TOC.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2021	SUPPL-43	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125504Orig1s043ltr.pdf
06/16/2020	SUPPL-35	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125504Orig1s035ltr.pdf
01/29/2020	SUPPL-31	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125504Orig1s031ltr.pdf
09/15/2017	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125504s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125504Orig1s016ltr.pdf
01/23/2018	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125504s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125504Orig1s013ltr.pdf
06/19/2018	SUPPL-5	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125504Orig1s005ltr.pdf
01/15/2016	SUPPL-2	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125504Orig1s001,s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125504Orig1s002.pdf
01/15/2016	SUPPL-1	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125504Orig1s001,s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125504Orig1s001.pdf

Labels for BLA 125504

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
05/28/2021	SUPPL-43	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504s043lbl.pdf
06/16/2020	SUPPL-35	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s035lbl.pdf
01/29/2020	SUPPL-31	Efficacy-New Dosing Regimen	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s031lbl.pdf
01/23/2018	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125504s013lbl.pdf
09/15/2017	SUPPL-16	Labeling-Medication Guide	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125504s016lbl.pdf
09/15/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125504s016lbl.pdf
01/15/2016	SUPPL-2	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf
01/15/2016	SUPPL-1	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf
01/21/2015	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf

Therapeutic Equivalents for BLA 125504

COSENTYX

There are no Therapeutic Equivalents.

منبع : www.accessdata.fda.gov

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COSENTYX از شرکت NOVARTIS PHARMS CORP