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Barr Gets FDA OK for Generic Pravachol


Posted on 2006-11-28 07:34:00



Barr Pharmaceuticals Inc. and its recently acquired unit Pliva said Tuesday the Food and Drug Administration approved their generic versions of Bristol-Myers Squibb Co.'s cholesterol drug Pravachol.

The FDA approved 10-milligram, 20-milligram and 40-milligram tablets of pravastatin, the active ingredient in Pravachol, and Barr plans to launch the products immediately.

These dosages of pravastatin brought in sales of about $1.2 billion for the 12-month period ending September, according to industry data.

Pliva also received approval on an 80-milligram tablet and plans to launch the product after a competitor's 180-day exclusivity period on the product expires.