вторник, 19 февраля 2008 г.

Teva announces tentative approval of generic prevacid® delayed-release capsules

And Drug Administration has granted tentative approval for thepany's Abbreviated New Drug Application (ANDA) to market its generic version of TAP Pharmaceutical's gastric-acid pump inhibitor, Prevacid(R) (Lansoprazole) Delayed-release Capsules, 15 mg and 30 mg.Product had annual sales of approximately $3.In the United States for the twelve months ended September 30, 2007, based on IMS sales data.Teva is currently in patent litigation concerning this product in the U.District Court for the District of Delaware involving Teva's paragraph IV certification to U.Patent Nos.5,045,321.Trial was held in November, at the end of which the Court indicated it anticipates it will issue a decision before the June 7, 2008 expiration of the mandatory 30-month stay of FDA approval associated with the patent litigation.ABOUT TEVA Teva Pharmaceutical Industries Ltd.In Israel, is among the top 20 pharmaceuticalpanies in the world and is the leading generic pharmaceuticalpany.Develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.80 percent of Teva's sales are in North America and Europe.SAFE HARBOR STATEMENT UNDER THE U.PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 This release contains forward-looking statements, which express the current beliefs and expectations of management.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.Factors that could cause or contribute to such differences include risks relating to: potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra(R), Neurontin(R), Lotrel(R) Famvir(R) and Protonix(R), Teva's ability to successfully develop andmercialize additional pharmaceutical products, the introduction ofpeting generic equivalents, the extent to which Teva may obtain U.Market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods,petition from brand-namepanies that are under increased pressure to counter generic products, orpetitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, the effects ofpetition on our innovative products, especially Copaxone(R) sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, whether and when the proposed acquisition of CoGenesys will be consummated, Teva's ability to rapidly integrate CoGenesys's operations with its own operations, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R"> HOW INTERESTING WAS THIS ARTICLE?Not Very.
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