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Abbott Laboratories submits Supplemental NDA for Biaxin for treatment of H. pylori infection; Abbott first to file for use of an antibiotic against ulcer-causing bacteria.


ABBOTT PARK, Ill.--(HealthWire)--Dec. 27, 1994--Abbott Laboratories has submitted a Supplemental New Drug Application with the U.S. Food and Drug Administration, seeking approval for the use of Biaxin(R) (clarithromycin) to treat Helicobacter pylori Helicobacter pylori
A gramnegative rod-shaped bacterium that lives in the tissues of the stomach and causes inflammation of the stomach lining.

Mentioned in: Indigestion, Ulcers

Helicobacter pylori
 (H. pylori Noun 1. H. pylori - the type species of genus Heliobacter; produces urease and is associated with several gastroduodenal diseases (including gastritis and gastric ulcers and duodenal ulcers and other peptic ulcers)
Heliobacter pylori
)-associated peptic ulcer disease Peptic ulcer disease (PUD)
A stomach disorder marked by corrosion of the stomach lining due to the acid in the digestive juices.

Mentioned in: Indigestion

peptic ulcer disease See Duodenal ulcer, Gastric ulcer, GERD.
.

According to according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 a National Institutes of Health Consensus Statement issued in February 1994, there is now evidence to indicate that H. pylori infection (in the absence of other precipitating factors) is causally related to the development of peptic ulcer disease, and that persistent infection accounts for the high rates of ulcer recurrence.

Results of Abbott's research and clinical development program suggest that dual therapy using the combination of Biaxin with the anti-secretory agent omeprazole omeprazole /omep·ra·zole/ (o-mep´ra-zol) an inhibitor of gastric acid secretion used in the treatment of dyspepsia , gastroesophageal reflux disease, disorders of gastric hypersecretion, and peptic ulcer, including that associated with  is a promising regimen for eradication of H. pylori infection and prevention of ulcer recurrence. The most common adverse events associated with the combination were taste perversion Perversion
See also Bestiality.

bondage and domination (B & D)

practices with whips, chains, etc. for sexual pleasure. [Western Cult.: Misc.
, nausea, headache, diarrhea, vomiting, abdominal pain, and infection. The application for the Abbott compound is the first to seek an indication for the use of an antibiotic to eradicate H. pylori infection.

Abbott Laboratories is a worldwide manufacturer of health care products, employing 50,000 people. In 1993, the company's sales and net earnings were $8.4 billion and $1.4 billion respectively, with earnings per share of $1.69.

CONTACT: Abbott Laboratories, Abbott Park
              Laureen Cassidy, 708/938-7743
              Douglas Petkus, 708/938-3531
COPYRIGHT 1994 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1994, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Dec 27, 1994
Words:226
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