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IVAX Confident ''First to File'' Status and Final Approval on Metformin ER Will Be Upheld
Business Wire, Oct 30, 2003
Business Editors/Health/Medical Writers
MIAMI--(BUSINESS WIRE)--Oct. 30, 2003
IVAX Corporation (AMEX:IVX)(LSE:IVX.L) said that Alpharma, Inc. (NYSE:ALO) brought legal action in the District Court in Washington, D.C. against the United States Food and Drug Administration (FDA), regarding the FDA's granting "first to file" status and final approval to IVAX' Metformin ER product. A temporary restraining order was granted against the FDA, pending a preliminary injunction hearing scheduled for November 12, 2003. Until the court rules on the preliminary injunction motion, IVAX will suspend further shipment of its Metformin ER product. The court has not ruled on the merits of the case and will consider the issues at the November 12th hearing. IVAX believes that Alpharma's position is completely without merit and that the FDA's actions were appropriate and correct. IVAX will participate in these proceedings and support the FDA position. IVAX is confident it will retain its "first to file" status and final approval for Metformin ER.
IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally.
Copies of this and other news releases may be obtained free of charge from IVAX' website at www.ivax.com.
Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements, including the statements regarding IVAX' first to file status and final approval for metformin ER, involve risks and uncertainties which may affect the company's business and prospects, including the risks that Alpharma's challenge of FDA's approval of IVAX' metformin ER may be successful and may result in revocation or suspension of IVAX' approval to market metformin ER; that Alpharma or other third parties may also seek damages against IVAX for patent infringement; as well as the general risks and uncertainties inherent generally in litigation; that sales of metformin ER may be impacted during the exclusivity period by licensing arrangements between Bristol-Myers and third party competitors; that exclusivity periods and the launch of metformin ER may be challenged by other third parties; the impact of the FDA's or other administrative or judicial agency's decisions on exclusivity periods; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission.
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