← FDA DRUG APPROVALS

FDA NDA · NDA209394

MAVYRET

glecaprevir and pibrentasvir

Sponsor: ABBVIE

APPLICATION
NDA209394
TYPE
NDA
ORIGINAL APPROVAL
2017-08-03
LATEST ACTION
2025-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MAVYRET · ReferencePrescription
GLECAPREVIR 100MG, PIBRENTASVIR 40MG · TABLET · ORAL

Approval history

2025-06-10Efficacy · Supplement 19 · priority — Label ↗AP
2025-04-15Manufacturing (CMC) · Supplement 18 — Label ↗AP
2023-10-25Labeling · Supplement 16 · standard — Letter ↗AP
2021-09-28Labeling · Supplement 14 · standard — Letter ↗AP
2021-06-10Efficacy · Supplement 13 · priority — Label ↗AP
2020-04-10Efficacy · Supplement 10 · standard — Label ↗AP
2019-09-26Efficacy · Supplement 7 · standard — Letter ↗AP
2019-09-26Efficacy · Supplement 8 · priority — Letter ↗AP
2019-04-30Efficacy · Supplement 6 · priority — Letter ↗AP
2018-08-06Efficacy · Supplement 2 · standard — Label ↗AP
2017-12-11Labeling · Supplement 3 · standard — Label ↗AP
2017-08-03Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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