Andrx Brings Suit Challenging FDA's Approval of Eon Labs' Bupropion HCl, ER 100mg Tablets.Business Editors LAURELTON, N.Y.--(BUSINESS WIRE)--Dec. 3, 2003 Eon Labs, Inc. (Nasdaq:ELAB) announced that Andrx Pharmaceuticals, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control has brought a suit against the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and Eon Labs, Inc. claiming that the FDA improperly granted approval of Eon's generic Bupropion bupropion /bu·pro·pi·on/ (bu-pro´pe-on) a monocyclic compound structurally similar to amphetamine, used as the hydrochloride salt as an antidepressant and as an aid in smoking cessation. HCl, ER 100mg tablets. The magistrate has recommended that a temporary restraining order temporary restraining order: see injunction. be entered which would prevent Eon from offering for sale or selling its generic Bupropion HCl, ER 100mg tablets. The magistrate's recommendation is subject to review by the district court judge. A decision by the district court judge on the recommendation is pending. Eon Labs is a generic pharmaceutical company specializing in developing, licensing, manufacturing, selling and distributing a broad range of prescription pharmaceutical products. For press releases and other company information, visit the Eon Labs, Inc. website at www.eonlabs.com. 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 statements that are forward-looking in nature which express the beliefs and expectations of management. Such statements are based on current plans, estimates and expectations and involve a number of known and unknown risks, uncertainties and other factors that could cause the Company's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . These factors and additional information are discussed in the Company's filings with the Securities and Exchange Commission and statements in this release should be evaluated in light of these important factors. Although we believe that these statements are based upon reasonable assumptions, we cannot guarantee future results. 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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