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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209394
Company: ABBVIE

Summary Review

Products on NDA 209394

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAVYRET	GLECAPREVIR; PIBRENTASVIR	100MG;40MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209394

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2017	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209394Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209394_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209394Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2023	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209394s016,215110s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209394Orig1s016;215110Orig1s003ltr.pdf
09/28/2021	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215110Orig1s001;209394Orig1s014ltr.pdf
06/10/2021	SUPPL-13	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215110s000,209394s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215110Orig1s000; 209394Orig1s013ltr.pdf
04/10/2020	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209394s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209394Orig1s010ltr.pdf
09/26/2019	SUPPL-8	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209394Orig1s008ltr.pdf
09/26/2019	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209394Orig1s007ltr.pdf
04/30/2019	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209394Orig1s006ltr.pdf
12/11/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209394Orig1s003ltr.pdf
08/06/2018	SUPPL-2	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209394s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209394Orig1s002ltr.pdf

Labels for NDA 209394

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209394s016,215110s003lbl.pdf
09/28/2021	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf
09/28/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf
06/10/2021	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215110s000,209394s013lbl.pdf
04/10/2020	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209394s010lbl.pdf
09/26/2019	SUPPL-8	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s008lbl.pdf
09/26/2019	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s007lbl.pdf
04/30/2019	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209394s006lbl.pdf
08/06/2018	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209394s002lbl.pdf
12/11/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s003lbl.pdf
08/03/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209394s000lbl.pdf

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