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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201917
Company: VERTEX PHARMS

FDA Press Release

Medication Guide

Other Important Information from FDA

Summary Review

Products on NDA 201917

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INCIVEK	TELAPREVIR	375MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201917

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2011	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201917Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201917Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201917Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/25/2014	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/28/2013	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201917Orig1s010,s012ltr.pdf
07/22/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
10/28/2013	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201917Orig1s010,s012ltr.pdf
05/08/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/25/2013	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201917Orig1s008ltr.pdf
12/14/2012	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201917Orig1s007ltr.pdf
11/27/2012	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/22/2012	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201917s004ltr.pdf
03/22/2012	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201917s003ltr.pdf

Labels for NDA 201917

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2013	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s012lbl.pdf
10/28/2013	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s010lbl.pdf
04/25/2013	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201917s008lbl.pdf
12/14/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s007lbl.pdf
12/14/2012	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s007lbl.pdf
06/22/2012	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s004lbl.pdf
03/22/2012	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s003lbl.pdf
03/22/2012	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201917s003lbl.pdf
05/23/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf

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