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Ivax, Alpharma settle Metformin ER suit

MiamiFriday, November 28, 2003, 08:00 Hrs  [IST]

Ivax Corporation has reached an agreement with Alpharma Inc. regarding Metformin ER. Under the agreement, Alpharma has withdrawn its lawsuit in US District Court for the District of Columbia against the United States Food and Drug Administration (FDA) under which Alpharma challenged the FDA's granting final approval and "first to file" status to Ivax for Metformin ER. In return, Ivax and Alpharma will share profits on an equal basis on all sales during the 180-day exclusivity period. Ivax will launch this product through its wholly-owned subsidiary Ivax Pharmaceuticals Inc. following reinstatement by FDA of Ivax' final approval for Metformin ER. Metformin ER is the generic equivalent of Glucophage XR, which is marketed by Bristol-Myers Squibb and used for the treatment of type 2 diabetes. US sales for Glucophage XR were over $453 million for the twelve months ending June 2003. Ivax Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the US and internationally.

 
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