Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201917
Company: VERTEX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INCIVEK TELAPREVIR 375MG TABLET;ORAL Discontinued None No No
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
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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