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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208051
Company: PUMA BIOTECH

Products on NDA 208051

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208051

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
06/28/2021	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208051s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208051Orig1s009ltr.pdf
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

Labels for NDA 208051

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2021	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208051s009lbl.pdf
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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