Printer Friendly
The Free Library
14,678,647 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Teva Announces Tentative Approval of Cetirizine HCL Tablets.


JERUSALEM -- Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in  Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA ANDA
abbr.
abbreviated new drug application
 for Cetirizine Hydrochloride ce·tir·i·zine hydrochloride
n.
A nonsedating antihistamine used to treat allergic rhinitis and other allergic disorders.


cetirizine hydrochloride 
 Tablets, 5 mg and 10 mg. Final approval is anticipated upon expiration of patent protection on December 25, 2007.

Teva's Cetirizine HCl cetirizine HCl,
n brand names: Reactine, Zyrtec;
drug class: antihistamine;
action: competitive antagonist for peripheral H1 receptors;
uses:
 Tablets are the AB-rated generic equivalent of Pfizer's antihistamine antihistamine (ăn'tĭhĭs`təmēn), any one of a group of compounds having various chemical structures and characterized by the ability to antagonize the effects of histamine.  product Zyrtec(R) Tablets, a product indicated for treatment of allergic rhinitis Allergic Rhinitis Definition

Allergic rhinitis, more commonly referred to as hay fever, is an inflammation of the nasal passages caused by allergic reaction to airborne substances.
 and chronic idiopathic urticaria urticaria /ur·ti·ca·ria/ (ur?ti-kar´e-ah) hives; a vascular reaction of the upper dermis marked by transient appearance of slightly elevated patches (wheals) which are redder or paler than the surrounding skin and often attended by .

The brand product has annual sales of approximately $1.2 billion.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva's sales are in North America and Europe.

Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 Statement under the U. S. Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, including its recent acquisition of Sicor Inc., the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:7ISRA
Date:Sep 22, 2004
Words:451
Previous Article:University of Chicago Opens New Business School Building.
Next Article:ConAgra Foods Reports Strong First Quarter Sales with Solid Profits; Share Repurchases Continued During the Quarter.
Topics:



Related Articles
Teva Announces Tentative Approval of Buspirone HCL Tablets, 15mg.
Teva Announces Tentative Approval of Metformin HCl Extended-Release Tablets.
Teva Announces Tentative Approval of Terbinafine HCl Tablets.
Teva Comments On The Court Of Appeals Decision Regarding Moexipril.
Teva Enters into Agreement with Schwarz Pharma to Suspend Sales of Moexipril Pending Outcome Of Litigation.
Teva Announces Tentative Approval of Metformin HCl Extended Release Tablets, 750 Mg.
Teva Launches Quinapril HCl Tablets; Pursuant to Agreement with Ranbaxy.
Teva Announces Tentative Approval of Fexofenadine HCl Tablets.
Efficacy and central nervous system impairment of newer-generation prescription antihistamines in seasonal allergic rhinitis.(Review Article)
FDA APPROVES TEVA'S ANDA TO MARKET GENERIC VERSION OF ZOCOR.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles