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Pharmaceutics

Teva. Another FDA approval  
 

 

Teva gets conditional approval for antacid drug

FDA grants Israeli generic pharmaceutical company conditional approval to manufacture, market 20mg Raberzazole Sodium tablet

Tani Goldstein
Published: 02.16.06, 16:00 / Israel Business

The U.S. Food and Drug Administration (FDA) granted Teva, the giant Israeli generic pharmaceutical company, a conditional approval to manufacture and market the 20mg Raberzazole Sodium tablet.

 

The drug is a generic version that Teva developed for the drug Aciphex developed by Eisai.

 

The drug is designed to treat stomach acid. Aciphex' sales in the US in 2005 totaled USD 1.2 Billion.

 

In 2003, Eisai filed a lawsuit against Teva in the southern district of New York, claiming that its patent on Aciphex had not yet expired and that Teva cannot distribute the drug.

 

The trial is not over yet. Teva could get a permanent approval to use the drug only when the patent expires in February 2007, or if and when it wins in court.

 

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