Healthcare Industry News: TYSABRI
News Release - May 25, 2006
Teva Announces Tentative Approval of Simvastatin TabletsProvides Update on 180-Day Exclusivity
JERUSALEM--(HSMN NewsFeed)--May 25, 2006--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA ) announced today that the U.S. Food and Drug Administration ("FDA") has granted tentative approval for the Company's Ivax Abbreviated New Drug Application ("ANDA") for Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg.
Upon final approval, the Company's Simvastatin Tablets will be the AB-rated generic equivalent of Merck's Zocor® Tablets, a product indicated for the treatment of high cholesterol. Total annual sales of the brand product are approximately $4.6 billion.
As the first company to file an ANDA containing a paragraph IV certification for the 5 mg, 10 mg, 20 mg, and 40 mg strengths, Teva is eligible to receive 180-day Hatch-Waxman statutory exclusivity to market these products.
Further, today the FDA filed an appeal to the United States Court of Appeals concerning Teva's 180-day exclusivity. The FDA is challenging a May 1, 2006 decision by the District Court, which found unlawful the FDA's October 24, 2005 decision denying the Company's citizen's petition on the exclusivity issue. The FDA is seeking expedited review and has proposed a schedule whereby the appeal will be fully briefed over the summer, with arguments to be heard at the Court's earliest convenience thereafter. Teva has agreed to an expedited schedule.
Teva expects to receive final approval for the 5 mg, 10 mg, 20 mg, and 40 mg strengths with exclusivity on June 23, 2006, when the product patent expires.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Close to 90% of Teva's sales are in North America and Europe.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act 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 risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the expected reintroduction of TYSABRI® into the 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, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, 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.
Source: Teva Pharmaceutical
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