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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
Sulfasalazine Enteric-Coated Tablets
国药准字H14022874
化学药品
片剂(肠溶)
6/22/2020
Sulfasalazine Enteric-Coated Tablets
国药准字H31020450
化学药品
片剂(肠溶)
8/13/2024
Sulfasalazine Enteric-Coated Tablets
国药准字H11020475
化学药品
片剂
2/26/2020
Sulfasalazine Enteric-Coated Tablets
国药准字H31020557
化学药品
片剂(肠溶)
11/26/2019
Sulfasalazine Enteric-Coated Tablets
国药准字H20054246
化学药品
片剂(肠溶糖衣)
12/11/2020
Sulfasalazine Enteric-Coated Tablets
国药准字H11020818
化学药品
片剂
6/16/2020
Sulfasalazine Enteric-Coated Tablets
国药准字H31020840
化学药品
片剂(肠溶薄膜衣)
1/10/2020
Sulfasalazine Suppositories
国药准字H19994081
化学药品
栓剂
6/16/2020
Sulfasalazine Suppositories
国药准字H20058244
化学药品
栓剂
7/13/2020
Sulfasalazine Suppositories
国药准字H20074194
化学药品
栓剂
8/18/2023

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

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