FDA Responds to Eon Labs' Metaxalone Biostudy.Business Editors LAURELTON, N.Y.--(BUSINESS WIRE)--March 24, 2003 Eon Labs, Inc. (Nasdaq: ELAB) announced today that it received a letter from 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. regarding its Metaxalone metaxalone /me·tax·a·lone/ (me-taks´ah-lon) a skeletal muscle relaxant used in the treatment of painful musculoskeletal conditions. 400mg product, the generic alternative for Skelaxin(R)*. In the letter, the FDA advised Eon Labs that it considers the bioequivalence bioequivalence /bio·equiv·a·lence/ (-e-kwiv´ah-lens) the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability. study for Eon's Metaxalone under food conditions not acceptable. The request by the FDA for this food study was triggered by a citizens petition by Elan (Emulated LAN) A virtual LAN in the ATM world. See LANE and virtual LAN. Elan - ["Top-down Programming with Elan", C.H.A. Koster, Ellis Horwood 1987]. , which was filed months after Eon Labs' original application was accepted by the FDA for filing. Eon Labs addressed the inconsistencies in the process in a pending citizens petition to the FDA submitted January 28, 2003. Eon Labs cannot predict the result or timing of a decision on this citizens petition. Eon Labs is evaluating its options and continues its effort to bring generic Metaxalone to market. 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. * Skelaxin(R) is a registered trademark of Elan Biopharmaceuticals and is not affiliated with Eon Labs, Inc. |
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