Treats acute bacterial skin and skin structure infections (ABSSSI) caused by designated…. NDA 205436, held by Cubist Pharms LLC. Tedizolid Phosphate.
As of Nov 14, 2026, NDA 205436 (Sivextro), held by Cubist Pharms LLC, was first approved by FDA on Jun 20, 2014, with 11 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 13Efficacy (new indication or use) · Standard review | Approved | |
| Jun 19, 2020 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Mar 6, 2019 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jun 20, 2014 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sivextro200MG/VIAL · powder;intravenous | Tedizolid Phosphate | RxReference drug |
| Feb 27, 2026 | Supplement 15Labeling · Standard review | Approved | |
| Apr 4, 2025 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Nov 17, 2021 | Supplement 9Labeling · Standard review | Approved | |
| Oct 22, 2020 | Supplement 8Labeling · Standard review | Approved | |
| Jun 19, 2020 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Sep 9, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Mar 6, 2019 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Aug 12, 2017 | Supplement 3Labeling · Standard review | Approved | |
| Aug 12, 2017 | Supplement 4Labeling · Standard review | Approved | |
| Oct 28, 2016 | Supplement 2Labeling · Standard review | Approved | |
| Mar 4, 2015 | Supplement 1Labeling · Standard review | Approved | |
| Jun 20, 2014 | Original applicationNew dosage form · 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
