Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203188
Company: VERTEX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KALYDECO IVACAFTOR 150MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/31/2012 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203188s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203188s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/31/2017 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s026,207925s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s026,207925Orig1s005ltr.pdf
01/11/2017 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/08/2017 SUPPL-22 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s022l_207925s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s022,207925Orig1s003ltr.pdf
05/20/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/17/2017 SUPPL-19 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203188Orig1s019,207925Orig1s001ltr.pdf
09/01/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/04/2015 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203188s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203188Orig1s017ltr.pdf
01/05/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/29/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s014,s015ltr.pdf
12/29/2014 SUPPL-14 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s014,s015ltr.pdf
12/11/2014 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/10/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/29/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/09/2015 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/24/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/08/2014 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s008ltr.pdf
06/13/2014 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s007ltr.pdf
02/21/2014 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203188Orig1s004ltr.pdf
12/13/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/03/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/28/2012 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203188Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/31/2017 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s026,207925s005lbl.pdf
05/17/2017 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s019lbl.pdf
02/08/2017 SUPPL-22 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203188s022l_207925s003lbl.pdf
03/04/2015 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203188s017lbl.pdf
12/29/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014s015lbl.pdf
12/29/2014 SUPPL-14 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s014lbl.pdf
06/13/2014 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s007lbl.pdf
04/08/2014 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s008lbl.pdf
02/21/2014 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203188s004lbl.pdf
08/28/2012 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188s001lbl.pdf
01/31/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203188lbl.pdf

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