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Teva Announces Tentative Approval of Divalproex Sodium Delayed-Release 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 Divalproex Sodium di·val·pro·ex sodium
n.
An anticonvulsant used in the treatment of petit mal and related seizure disorders.


divalproex sodium

Depakote, Depakote ER, Depakote Sprinkle

Pharmacologic class:
 Delayed-Release Tablets USP USP - unique sales point , 125 mg, 250 mg and 500 mg. Final approval of this product is anticipated upon expiration of patent protection for the brand product in January 2008.

Upon final approval, Teva's Divalproex Sodium Delayed-Release Tablets will be the AB-rated generic equivalent of Abbott's Depakote(R) Tablets. This product is indicated for treatment of manic episodes associated with bipolar disorder bipolar disorder, formerly manic-depressive disorder or manic-depression, severe mental disorder involving manic episodes that are usually accompanied by episodes of depression. , prophylaxis of migraine headaches, and as therapy in several types of epileptic epileptic /ep·i·lep·tic/ (ep?i-lep´tik)
1. pertaining to or affected with epilepsy.

2. a person affected with epilepsy.


ep·i·lep·tic
n.
One who has epilepsy.
 disorders.

The brand product has annual sales of approximately $813 million.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 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 management's current beliefs and 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 whether and when the proposed acquisition of IVAX Corporation will be consummated and the terms of any conditions imposed in connection with such closing, the terms and conditions of the financing utilized by Teva for the IVAX IVAX Industrial Vax (Dec Computer)  acquisition, Teva's ability to rapidly integrate IVAX's operations and achieve expected synergies, 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 or license their own generic products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic products, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final court decision, including that relating to the generic versions of Allegra(R), Neurontin(R), Oxycontin Ox·y·con·tin

A trademark for the drug oxycodone.


oxycodone hydrochloride

ETH-Oxydose, OxyContin, OxyFast, Oxy-IR, Oxynorm (UK), Roxicodone, Supeudol (CA)

Pharmacologic class: Opioid agonist
(R) and Zithromax(R), the effects of competition on Copaxone(R) sales, 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, European Medicines Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations outside the United States that may be adversely affected by terrorism or major hostilities, 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.
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Comment:Teva Announces Tentative Approval of Divalproex Sodium Delayed-Release Tablets.
Publication:Business Wire
Geographic Code:7ISRA
Date:Jan 12, 2006
Words:555
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