SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| SIVEXTRO 200 mg film-coated tablet | 200 mg | Film-coated tablet · Oral use | 6 Blister | SAR 4810.65 | NCE · Prescription | BAYER PHARMA AG | Withdrawn by MAH · Not Marketed |
| SIVEXTRO 200 mg injection | 200 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 954.95 | NCE · Prescription | BAYER PHARMA AG | Withdrawn by MAH · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| SIVEXTRO | 200MG | tablet · oral | CUBIST PHARMS LLC | Prescription | 20 Jun 2014 |
| SIVEXTRO | 200MG/VIAL | powder · intravenous | CUBIST PHARMS LLC | Prescription | 20 Jun 2014 |
EMA European Union — centrally authorised medicines
Sivextro Merck Sharp & Dohme B.V. · Authorised · authorised 23 Mar 2015 · ATC J01XX11
Therapeutic indication (EMA)
Sivextro tablets are indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults, adolescents and children weighing at least 35 kg. Sivextro powder for concentrate for solution for infusion is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) from birth. Sivextro powder for oral suspension is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in patients from birth. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | SIVEXTRO 200 MG TABLET | $475.79029 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 6.2.3. Reserve group antibiotics · complementary
Therapeutic equivalent to linezolid for Methicillin resistant Staphylococcus aureus; Therapeutic equivalent to linezolid for Vancomycin resistant Staphylococcus aureus; Therapeutic equivalent to linezolid for Vancomycin resistant Enterococcus
Safety signals and safety-related labeling changes
- US FDA 27 Feb 2026 SIVEXTRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 27 Feb 2026 SIVEXTRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
All safety entries for tedizolid →
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.