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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202324
Company: PF PRISM CV

Summary Review

Products on NDA 202324

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INLYTA	AXITINIB	1MG	TABLET;ORAL	Prescription	None	Yes	No
INLYTA	AXITINIB	5MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202324

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202324lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202324s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202324Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202324Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2022	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202324Orig1s014CorrectedLbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202324Orig1s014Correctedltr.pdf
06/04/2020	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202324s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202324Orig1s011ltr.pdf
01/23/2020	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202324s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202324Orig1s010ltr.pdf
08/10/2018	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202324s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202324Orig1s008ltr.pdf
06/16/2016	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/30/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/29/2014	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202324Orig1s003ltr.pdf
08/01/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202324Orig1s002ltr.pdf
09/16/2013	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202324s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202324Orig1s001ltr.pdf

Labels for NDA 202324

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2022	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202324Orig1s014CorrectedLbl.pdf
06/04/2020	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202324s011lbl.pdf
01/23/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202324s010lbl.pdf
08/10/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202324s008lbl.pdf
12/29/2014	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324Orig1s003lbl.pdf
08/01/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324s002lbl.pdf
09/16/2013	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202324s001lbl.pdf
01/27/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202324lbl.pdf

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