MedPath

Taurine

Generic Name
Taurine
Brand Names
Aminosyn-PF 7%, Premasol, Primene, Trophamine 10 %
Drug Type
Small Molecule
Chemical Formula
C2H7NO3S
CAS Number
107-35-7
Unique Ingredient Identifier
1EQV5MLY3D

Overview

Taurine, whose chemical name is 2-aminoethanesulfonic acid, is one of the most abundant amino acids in several organs. It plays important role in essential biological processes. This conditional amino acid can be either be manufactured by the body or obtained in the diet mainly by the consumption of fish and meat. The supplements containing taurine were FDA approved by 1984 and they are hypertonic injections composed by cristalline amino acids.

Indication

The use of diet supplements containing taurine is indicated for the nutritional support of infants and young pediatric patients requiring total parenteral nutrition via central or peripheral routes. The usage of diet supplements containing taurine prevents nitrogen and weight loss or to treat negative nitrogen balance in pediatric patients where the alimentary tract cannot be done through oral, gastrostomy or jejunostomy administration, there is impaired gastrointestinal absorption or protein requirements are substantially increased.

Associated Conditions

No associated conditions information available.

Clinical Trials

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Baxter Healthcare Corporation
0338-1131
INTRAVENOUS
15 mg in 100 mL
8/4/2022
B. Braun Medical Inc.
0264-1933
INTRAVENOUS
0.025 g in 100 mL
8/22/2022
Bispit Canada Ltd.
85631-004
ORAL
30 mg in 1.2 g
8/3/2025
ICU Medical Inc.
0990-4178
INTRAVENOUS
50 mg in 100 mL
9/21/2021
Baxter Healthcare Corporation
0338-1130
INTRAVENOUS
25 mg in 100 mL
8/4/2022
ICU Medical Inc.
0990-4179
INTRAVENOUS
70 mg in 100 mL
7/19/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
SmofKabiven Emulsion for Infusion
SIN14286P
INJECTION, EMULSION
1.0g /1000ml
1/8/2013
SmofKabiven Electrolyte Free Emulsion for Infusion
SIN14292P
INJECTION, EMULSION
1.0g /1000ml
1/16/2013
TROPHAMINE INJECTION 10%
SIN07846P
INJECTION
0.025 g/100 ml
9/12/1994
SmofKabiven Peripheral Emulsion for Infusion
SIN14287P
INJECTION, EMULSION
1.0g /1000ml
1/8/2013
SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE-FREE EMULSION FOR INFUSION
SIN16136P
INJECTION, EMULSION
0.65g/1000ml
3/24/2021
VAMINOLACT INTRAVENOUS SOLUTION
SIN07428P
INJECTION
300 mg/1000 ml
5/12/1993
AMINOVEN SOLUTION FOR INFUSION 15%
SIN16337P
INFUSION, SOLUTION
2g/L
9/30/2021
AMINOVEN SOLUTION FOR INFUSION 10%
SIN11829P
INJECTION
1.000 g/1000 ml
2/28/2002
PRIMENE 10% AMINO ACID INTRAVENOUS INFUSION
SIN10252P
INJECTION
0.6 g/l
9/23/1998
AMINOVEN SOLUTION FOR INFUSION 5%
SIN11682P
INJECTION
0.500 g/1000 ml
9/25/2001

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
VAMINOLACT I.V. SOLUTION
N/A
N/A
N/A
10/14/1992

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
AMINOSYN-PF 10%
hospira healthcare ulc
00731366
Solution - Intravenous
70 MG / 100 ML
12/31/1990
PRIMENE 10%-LIQ IV
clintec nutrition company
02161192
Liquid - Intravenous
60 MG / 100 ML
12/31/1995
PRIMENE 10%
baxter corporation
02236875
Liquid - Intravenous
60 MG / 100 ML
11/14/1997
ESSEPNA
fresenius kabi canada ltd
02510324
Solution - Intravenous
0.1 G / 100 ML
1/25/2023
SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE
fresenius kabi canada ltd
02501775
Emulsion - Intravenous
0.65 G / 100 ML
7/9/2021
SMOFKABIVEN PERIPHERAL
fresenius kabi canada ltd
02456206
Emulsion - Intravenous
32 MG / 100 ML
2/14/2017
AMINOSYN-PF 7%
hospira healthcare ulc
00731358
Solution - Intravenous
50 MG / 100 ML
12/31/1990
SMOFKABIVEN
fresenius kabi canada ltd
02440695
Emulsion - Intravenous
0.05 G / 100 ML
9/15/2015
ESSENTIALS PLUS - TAB
alive international
02229851
Tablet - Oral
0.5 MG
1/28/1997
SMOFKABIVEN EXTRA NITROGEN
fresenius kabi canada ltd
02501813
Emulsion - Intravenous
0.065 G / 100 ML
5/5/2021

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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