Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208051
Company: PUMA BIOTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NERLYNX NERATINIB MALEATE EQ 40MG BASE 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
07/17/2017 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208051s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208051Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208051Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2020 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208051s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208051Orig1s007ltr.pdf
02/25/2020 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208051s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208051Orig1s005,s006ltr.pdf
02/25/2020 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208051s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208051Orig1s005,s006ltr.pdf
10/01/2019 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208051s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208051Orig1s004ltr.pdf
04/18/2019 SUPPL-3 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208051Orig1s003ltr.pdf
06/28/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208051s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208051Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/29/2020 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208051s007lbl.pdf
02/25/2020 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208051s005s006lbl.pdf
02/25/2020 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208051s005s006lbl.pdf
10/01/2019 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208051s004lbl.pdf
06/28/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208051s002lbl.pdf
07/17/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208051s000lbl.pdf

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