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Tedizolid phosphate

Generic Name
Tedizolid phosphate
Brand Names
Sivextro
Drug Type
Small Molecule
Chemical Formula
C17H16FN6O6P
CAS Number
856867-55-5
Unique Ingredient Identifier
O7DRJ6R4DW

Overview

Drug-resistant bacteria, such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, and penicillin-resistant Streptococcus penumoniae, represent a massive public health threat. Tedizolid is a member of the oxazolidinone class of antibiotics, which includes the previously approved linezolid and is generally effective against multidrug-resistant Gram-positive bacteria. Tedizolid is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is generally more effective and more tolerable than linezolid. Tedizolid was approved by the FDA on June 20, 2014, for sale by Cubist Pharmaceuticals as tedizolid phosphate (SIVEXTRO®). This product is currently available as both an oral tablet and as a powder for intravenous injection.

Background

Drug-resistant bacteria, such as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, and penicillin-resistant Streptococcus penumoniae, represent a massive public health threat. Tedizolid is a member of the oxazolidinone class of antibiotics, which includes the previously approved linezolid and is generally effective against multidrug-resistant Gram-positive bacteria. Tedizolid is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and is generally more effective and more tolerable than linezolid. Tedizolid was approved by the FDA on June 20, 2014, for sale by Cubist Pharmaceuticals as tedizolid phosphate (SIVEXTRO®). This product is currently available as both an oral tablet and as a powder for intravenous injection.

Indication

Tedizolid is indicated for the treatment of acute bacterial infections of the skin and skin structure (ABSSSI). To prevent drug resistance, tedizolid should only be used for infections that are caused by susceptible bacteria.

Associated Conditions

  • Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code

No FDA products found

No FDA products found for this drug

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision

No EMA products found

No EMA products found for this drug

Singapore Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.
Online

No Singapore products found

No Singapore products found for this drug

China Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import
Tedizolid Phosphate Tablets
国药准字H20234209
片剂
N/A
200mg
Chemical Drug
Approved
2023/09/28
Domestic
Tedizolid Phosphate Tables
国药准字H20234566
片剂
N/A
200mg
Chemical Drug
Approved
2023/11/28
Domestic
Tedizolid Phosphate Tablets
国药准字H20223933
片剂
N/A
200mg
Chemical Drug
Approved
2022/12/30
Domestic
Tedizolid Phosphate Tablet
国药准字H20244338
片剂
N/A
200mg
Chemical Drug
Approved
2024/06/28
Domestic
Tedizolid Phosphate Tablets
国药准字H20243454
片剂
N/A
200mg
Chemical Drug
Approved
2024/04/07
Domestic
Tedizolid Phosphate Tablets
国药准字H20234508
片剂
N/A
200mg
Chemical Drug
Approved
2023/11/21
Domestic
Tedizolid Phosphate Tablets
国药准字H20249604
片剂
N/A
200mg
Chemical Drug
Approved
2024/12/01
Domestic
Tedizolid Phosphate Tablets
国药准字H20223959
片剂
N/A
200mg
Chemical Drug
Approved
2022/12/30
Domestic
Tedizolid Phosphate Tablets
H20190029
片剂
赛威乐
200mg
Chemical Drug
Expired
2019/06/13
Import
Tedizolid Phosphate Tablets
国药准字H20243435
片剂
N/A
0.2g
Chemical Drug
Approved
2024/04/07
Domestic

Australia Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient

No Australia products found

No Australia products found for this drug

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