Ivax Corporation reported that Alpharma, Inc. 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.