Treats acute bacterial skin and skin structure infections (ABSSSI) caused by designated…. NDA 205435, held by Cubist Pharms LLC. Tedizolid Phosphate.
As of Nov 14, 2026, NDA 205435 (Sivextro), held by Cubist Pharms LLC, was first approved by FDA on Jun 20, 2014, with 15 approved supplements and 0 published complete response letters.
SIVEXTRO is an oxazolidinone antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible microorganisms in adult and pediatric patients (at least 26 weeks gestational age and weighing at least 1 kg) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Acute Bacterial Skin and Skin Structure Infections
| Apr 4, 2025 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Jun 19, 2020 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Mar 6, 2019 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jun 20, 2014 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sivextro200MG · tablet;oral | Tedizolid Phosphate | RxReference drug |
| Feb 27, 2026 | Supplement 19Labeling · Standard review | Approved | |
| Apr 4, 2025 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Nov 17, 2021 | Supplement 14Labeling · Standard review | Approved | |
| Oct 22, 2020 | Supplement 13Labeling · Standard review | Approved | |
| Jun 19, 2020 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Sep 9, 2019 | Supplement 11Labeling · Standard review | Approved | |
| Mar 6, 2019 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Aug 12, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Aug 12, 2017 | Supplement 8Labeling · Standard review | Approved | |
| Nov 1, 2016 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Oct 28, 2016 | Supplement 3Labeling · Standard review | Approved | |
| Sep 16, 2016 | Supplement 6Labeling · Standard review | Approved | |
| Jun 5, 2016 | Supplement 5Labeling · Standard review | Approved | |
| Aug 11, 2015 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Mar 4, 2015 | Supplement 1Labeling · Standard review | Approved | |
| Jun 20, 2014 | Original applicationNew molecular entity · Priority 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
