Current FDA-approved treatments for Helicobacter pylori and the FDA approval process

Gastroenterology

Volumn 113, Issue 6 SUPPL., 1997, Pages

  Hopkins, R J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BISMUTH CITRATE; CLARITHROMYCIN; HISTAMINE H2 RECEPTOR ANTAGONIST; METRONIDAZOLE; OMEPRAZOLE; RANITIDINE; TETRACYCLINE DERIVATIVE;

ANTIBIOTIC SENSITIVITY; ANTIMICROBIAL ACTIVITY; CONFERENCE PAPER; DRUG EFFICACY; DUODENUM ULCER; HELICOBACTER PYLORI; INTESTINE INFECTION; PRIORITY JOURNAL; TREATMENT OUTCOME;

EID: 0030779814     PISSN: 00165085     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0016-5085(97)80026-1     Document Type: Conference Paper

References (9)

1. RJ Hopkins LS Girardi E Turney Relationship between Helicobacter pylori eradication and reduced duodenal ulcer recurrence: a review Gastroenterology 110 1996 1244 1252
2. DAIDP Points to Consider Document: March 1995 Addendum Draft (June 1995 Revision), Helicobacter pylori -associated peptic ulcer disease, Indication #25.
3. http://www.fda.gov/cder/guidance/ptc.htm
4. DY Graham GM Lew DG Evans DJ Evans Jr PD Klein Effect of triple therapy (antibiotics plus bismuth) on duodenal ulcer healing: a randomized controlled trial Ann Intern Med 115 1991 266 269
5. DY Graham GM Lew PD Klein DG Evans DJ Evans Jr ZA Saeed HM Malaty Effect of treatment of Helicobacter pylori infection on the long-term recurrence of gastric or duodenal ulcer: a randomized, controlled study Ann Intern Med 116 1992 705 708
6. AF Cutler T Schubert Patient factors affecting Helicobacter pylori eradication with triple therapy Am J Gastroenterol 88 1993 505 509
7. AF Cutler T Schubert Long-term Helicobacter pylori recurrence after successful eradication with triple therapy Am J Gastroenterol 88 1993 1359 1361
8. Evaluating clinical studies of antimicrobials in the Division of Anti-Infective Drug Products: Indication #25 Helicobacter pylori proposed.
9. http://www.fda.gov/cder/guidance.htm