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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207103
Company: PFIZER

Summary Review

Products on NDA 207103

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBRANCE	PALBOCICLIB	75MG	CAPSULE;ORAL	Prescription	None	Yes	No
IBRANCE	PALBOCICLIB	100MG	CAPSULE;ORAL	Prescription	None	Yes	No
IBRANCE	PALBOCICLIB	125MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207103

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207103Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207103Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207103Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2023	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207103s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207103Orig1s017,s018ltr.pdf
09/06/2023	SUPPL-17	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207103s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207103Orig1s017,s018ltr.pdf
12/13/2022	SUPPL-15	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207103s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207103Orig1s015;212436Orig1s003ltr.pdf
09/09/2019	SUPPL-12	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207103Orig1s012ltr.pdf
09/09/2019	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207103Orig1s011ltr.pdf
02/19/2019	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207103Orig1s010ltr.pdf
04/04/2019	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207103Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/207103Orig1s008.pdf
02/06/2018	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207103s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207103Orig1s007ltr.pdf
03/31/2017	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207103s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207103Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/207103Orig1s004.pdf
02/19/2016	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207103s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207103Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207103Orig1s002.pdf
12/17/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 207103

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207103s017s018lbl.pdf
09/06/2023	SUPPL-17	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207103s017s018lbl.pdf
12/13/2022	SUPPL-15	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207103s015lbl.pdf
09/09/2019	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103Orig1s012lbl.pdf
09/09/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103Orig1s012lbl.pdf
09/09/2019	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s011lbl.pdf
04/04/2019	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s008lbl.pdf
02/19/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s010lbl.pdf
02/06/2018	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207103s007lbl.pdf
03/31/2017	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207103s004lbl.pdf
02/19/2016	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207103s002lbl.pdf
02/03/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf

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