Treats chronic hepatitis B virus (HBV) infection. NDA 208464, held by Gilead Sciences Inc. Tenofovir Alafenamide Fumarate.
As of Nov 13, 2026, NDA 208464 (Vemlidy), held by Gilead Sciences Inc, was first approved by FDA on Nov 10, 2016, with 12 approved supplements and 0 published complete response letters.
VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.
| Mar 27, 2024 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Mar 27, 2024 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Oct 17, 2022 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Aug 18, 2020 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Aug 18, 2020 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Feb 4, 2020 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Feb 4, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jul 3, 2018 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Nov 10, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| VemlidyEQ 25MG BASE · tablet;oral | Tenofovir Alafenamide Fumarate | RxReference drug |
| Mar 27, 2024 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Mar 27, 2024 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Dec 14, 2022 | Supplement 15Manufacturing | Approved | |
| Oct 17, 2022 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Sep 15, 2021 | Supplement 13Labeling · Standard review | Approved | |
| Mar 4, 2021 | Supplement 12Labeling · Standard review | Approved | |
| Aug 18, 2020 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Aug 18, 2020 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Feb 4, 2020 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Feb 4, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jul 3, 2018 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Apr 7, 2017 | Supplement 1Labeling · Standard review | Approved | |
| Nov 10, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
