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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210251
Company: GILEAD SCIENCES INC

Products on NDA 210251

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIKTARVY	BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes
BIKTARVY	BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210251

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/2018	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210251Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210251Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2024	SUPPL-18	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210251s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210251Orig1s018ltr.pdf
05/01/2023	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210251Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210251Orig1s017ltr.pdf
10/14/2022	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210251s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210251Orig1s015ltr.pdf
10/07/2021	SUPPL-14	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s014ltr.pdf
09/10/2021	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s013ltr.pdf
03/04/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s010ltr.pdf
02/11/2021	SUPPL-9	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s009ltr.pdf
02/24/2021	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s008ltr.pdf
02/05/2021	SUPPL-7	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s007ltr.pdf
08/02/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210251Orig1s006ltr.pdf
06/18/2019	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210251Orig1s005ltr.pdf

Labels for NDA 210251

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2024	SUPPL-18	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210251s018lbl.pdf
05/01/2023	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210251Orig1s017lbl.pdf
10/14/2022	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210251s015lbl.pdf
10/07/2021	SUPPL-14	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s014lbl.pdf
09/10/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s013lbl.pdf
09/10/2021	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s013lbl.pdf
03/04/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s010lbl.pdf
02/24/2021	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s008lbl.pdf
02/11/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s009lbl.pdf
02/11/2021	SUPPL-9	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s009lbl.pdf
02/05/2021	SUPPL-7	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s007lbl.pdf
08/02/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s006lbl.pdf
06/18/2019	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s005lbl.pdf
02/07/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf

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