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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213246
Company: LOXO ONCOL ELI LILLY

Products on NDA 213246

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RETEVMO	SELPERCATINIB	40MG	CAPSULE;ORAL	Prescription	None	Yes	No
RETEVMO	SELPERCATINIB	80MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213246

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213246s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213246Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213246Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2024	SUPPL-13	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213246Orig1s011; s013ltr.pdf
05/29/2024	SUPPL-12	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213246Orig1s012ltr.pdf
09/27/2024	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213246Orig1s011; s013ltr.pdf
04/10/2024	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213246Orig1s010ltr.pdf
06/12/2024	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213246Orig1s009ltr.pdf
09/21/2022	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213246s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213246Orig1s008ltr.pdf
09/21/2022	SUPPL-7	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213246s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213246Orig1s007ltr.pdf
01/28/2021	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213246s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213246Orig1s002ltr.pdf

Labels for NDA 213246

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/27/2024	SUPPL-13	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s011s013lbl.pdf
09/27/2024	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s011s013lbl.pdf
06/12/2024	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s009lbl.pdf
05/29/2024	SUPPL-12	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.pdf
04/10/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s010lbl.pdf
09/21/2022	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213246s008lbl.pdf
09/21/2022	SUPPL-7	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213246s007lbl.pdf
01/28/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213246s002lbl.pdf
05/08/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213246s000lbl.pdf

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