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Sulfasalazine

Generic Name
Sulfasalazine
Brand Names
Azulfidine, Salazopyrin, Salazopyrin En-tabs
Drug Type
Small Molecule
Chemical Formula
C18H14N4O5S
CAS Number
599-79-1
Unique Ingredient Identifier
3XC8GUZ6CB

Overview

Sulfasalazine is an anti-inflammatory drug structurally related to salicylates and other non-steroidal anti-inflammatory drugs. It is indicated for managing inflammatory diseases such as ulcerative colitis and rheumatoid arthritis (RA). Metabolized by intestinal bacteria, sulfasalazine is broken down into mesalazine and sulfapyridine, 2 compounds that carry out the main pharmacological activity of sulfasalazine. Sulfasalazine was first used in 1940 for rheumatic polyarthritis, and has been firmly established itself as one fo the most useful disease-modifying antirheumatic drug (DMARD). Compared to the first line treatment of RA like methotrexate, sulfasalazine is almost as efficacious as methotrexate although with slightly less tolerability. However, sulfasalazine has less teratogenic side effects and faster onset of action compared to conventional DMARD. Sulfasalazine fell out of favor as the drug of choice for RA due to poorly designed clinical trials in 1950 but regained interest from the clinical community in the late 1970. Although sulfasalazine is only approved by the FDA for ulcerative colitis, research have shown that sulfasalazine is also beneficial for patients with Crohn's disease. Meta-analysis of 19 randomized controlled trials indicated that sulfasalazine is superior to placebo in inducing remission; however, with no supported evidence of mucosal healing, sulfasalazine is not FDA-recommmended for treatment of Crohn's disease.

Indication

In the US, sulfasalazine is indicated to treat mild to moderate ulcerative colitis and to prolong the remission period between acute attacks of ulcerative colitis. Sulfasalazine is also indicated as an adjunct therapy in severe ulcerative colitis.For the delayed-release tablet formulation, sulfasalazine is also indicated to treat rheumatoid arthritis in pediatric patients who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs or polyarticular-course juvenile rheumatoid arthritis with the same patients' characteristics.

Associated Conditions

  • Crohn's Disease (CD)
  • Distal Ulcerative Colitis
  • Mild to Moderate Ulcerative Colitis
  • Polyarticular juvenile rheumatoid arthritis, chronic or unspecified
  • Proctitis
  • Rheumatoid Arthritis
  • Severe Ulcerative Colitis
  • Ulcerative Colitis in Remission

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Blenheim Pharmacal, Inc.
10544-288
ORAL
500 mg in 1 1
2/25/2015
Pfizer Laboratories Div Pfizer Inc
0013-0101
ORAL
500 mg in 1 1
10/26/2022
A-S Medication Solutions
50090-6936
ORAL
500 mg in 1 1
10/31/2022
REMEDYREPACK INC.
70518-0185
ORAL
500 mg in 1 1
1/4/2024
Actavis Pharma, Inc.
0591-0796
ORAL
500 mg in 1 1
2/28/2022
Aphena Pharma Solutions - Tennessee, LLC
43353-495
ORAL
500 mg in 1 1
7/3/2014
Greenstone LLC
59762-5000
ORAL
500 mg in 1 1
10/31/2022
Aidarex Pharmaceuticals LLC
33261-756
ORAL
500 mg in 1 1
2/1/2014
Aphena Pharma Solutions - Tennessee, LLC
71610-706
ORAL
500 mg in 1 1
5/16/2023
Pfizer Laboratories Div Pfizer Inc
0013-0102
ORAL
500 mg in 1 1
10/27/2022

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
PMS-SULFASALAZINE E.C.TABLET 500 mg
SIN06512P
ENTERIC COATED TABLET
500 mg
8/19/1991

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
SARIDINE-E ENTERIC COATED TAB 500MG
N/A
N/A
N/A
8/3/2011

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Salazopyrin EN - TABS sulfasalazine 500mg tablet
14485
Medicine
A
9/5/1991
Salazopyrin sulfasalazine 500mg tablet
14486
Medicine
A
9/5/1991
PYRALIN EN Sulfasalazine 500mg tablet
58398
Medicine
A
2/27/1997

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
JAMP SULFASALAZINE
02544652
Tablet - Oral
500 MG
N/A
SAS ENEMA 3GM/100ML
icn canada ltd.
00613568
Enema - Rectal
3 G / 100 ML
12/31/1984
APO SULFASALAZINE TAB 500MG
00410640
Tablet - Oral
500 MG
12/31/1978
PMS-SULFASALAZINE-E.C. TAB 500MG
00598488
Tablet (Enteric-Coated) - Oral
500 MG
12/31/1984
RATIO-SULFASALAZINE EN
ratiopharm inc division of teva canada limited
00685925
Tablet (Enteric-Coated) - Oral
500 MG
12/31/1986
SAS TAB 500MG
icn canada ltd.
00263869
Tablet - Oral
500 MG
12/31/1973
PMS-SULFASALAZINE 500MG/TAB USP
00598461
Tablet - Oral
500 MG
12/31/1984
S.A.S. ENTERIC 500MG
icn canada ltd.
00445126
Tablet (Enteric-Coated) - Oral
500 MG
12/31/1979
ORB-SULFASALAZINE EC
orbus pharma inc
02246803
Tablet (Enteric-Coated) - Oral
500 MG
N/A
SALAZOPYRIN EN-TABS 500 MG
02064472
Tablet (Enteric-Coated) - Oral
500 MG
12/31/1995

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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