Mylan announces tentative approval for Rabeprazole sodium delayed-release tablets

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Jan 23 2006

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Mylan Laboratories Inc. has announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Rabeprazole Sodium Delayed-release Tablets, 20 mg.

Rabeprazole Sodium Delayed-release Tablets are the generic version of Eisai Medical Research Inc.'s Aciphex(R) Tablets, which had annual U.S. sales of approximately $1.3 billion as of June 2005.

Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories, Inc. that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.

Source:

http://www.mylan.com/

Posted in: Pharmaceutical News

Tags: Food, Generic Drug, Medical Research, New Drug Application, Pharmaceuticals, Research

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