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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210854
Company: GENENTECH INC

Products on NDA 210854

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XOFLUZA	BALOXAVIR MARBOXIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
XOFLUZA	BALOXAVIR MARBOXIL	40MG	TABLET;ORAL	Prescription	AB	Yes	No
XOFLUZA	BALOXAVIR MARBOXIL	80MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210854

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210854s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210854Orig1s000ltr_ReplacementLtr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210854Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/2025	SUPPL-24		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210854Orig1s024lbl.pdf
05/30/2025	SUPPL-23	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210854Orig1s023,214410Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210854Orig1s023,214410Orig1s008ltr.pdf
12/19/2024	SUPPL-21	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s021,214410s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210854Orig1s021;214410Orig1s007ltr.pdf
03/01/2024	SUPPL-20	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s020,214410s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210854Orig1s020; 214410Orig1s006ltr.pdf
06/15/2023	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210854s018,214410s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210854Orig1s018;214410Orig1s005ltr.pdf
11/23/2020	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214410s000,210854s004s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214410Orig1s000; 210854Orig1s004, s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214410Orig1s000, 210854Orig1s004, s010TOC.html
08/11/2022	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210854s005s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210854Orig1s005, s009ltr.pdf
03/18/2021	SUPPL-8			Label is not available on this site.
08/11/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210854s005s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210854Orig1s005, s009ltr.pdf
11/23/2020	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214410s000,210854s004s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214410Orig1s000; 210854Orig1s004, s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214410Orig1s000, 210854Orig1s004, s010TOC.html
10/16/2019	SUPPL-1	Efficacy-New Patient Population	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210854s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210854Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210854Orig1s001.pdf

Labels for NDA 210854

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/30/2025	SUPPL-23	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210854Orig1s023,214410Orig1s008lbl.pdf
01/29/2025	SUPPL-24	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210854Orig1s024lbl.pdf
12/19/2024	SUPPL-21	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s021,214410s007lbl.pdf
03/01/2024	SUPPL-20	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210854s020,214410s006lbl.pdf
06/15/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210854s018,214410s005lbl.pdf
08/11/2022	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210854s005s009lbl.pdf
08/11/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210854s005s009lbl.pdf
11/23/2020	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214410s000,210854s004s010lbl.pdf
11/23/2020	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214410s000,210854s004s010lbl.pdf
10/16/2019	SUPPL-1	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210854s001lbl.pdf
10/24/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210854s000lbl.pdf

Therapeutic Equivalents for NDA 210854

XOFLUZA

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BALOXAVIR MARBOXIL	BALOXAVIR MARBOXIL	40MG	TABLET;ORAL	Prescription	No	AB	217449	NORWICH
XOFLUZA	BALOXAVIR MARBOXIL	40MG	TABLET;ORAL	Prescription	Yes	AB	210854	GENENTECH INC

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BALOXAVIR MARBOXIL	BALOXAVIR MARBOXIL	80MG	TABLET;ORAL	Prescription	No	AB	217449	NORWICH
XOFLUZA	BALOXAVIR MARBOXIL	80MG	TABLET;ORAL	Prescription	Yes	AB	210854	GENENTECH INC

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