Issue 162 Item 3 FDA Clears Bristol-Myers to Co-Package Statin With Aspirin Call

Bristol-Myers Squibb Company announced on Thursday that it received approval from the U.S. Food and Drug Administration (FDA) to market Pravachol (pravastatin) in combination with low-dose aspirin under a new brand name, Pravigard PAC The co-packaged product will be marketed to patients needing both a statin and buffered aspirin and will be priced at the same wholesale price as Pravachol.

Advisors to the FDA had endorsed approval of the co-packaged product in July 2002 for the prevention of various cardiovascular events, including acute heart attacks, in at risk-patients, provided that the drugmaker market several separate doses.

The FDA panel said it was unlikely to support a fixed dose tablet, which may have enjoyed separate patent protection, due to potential unforeseen complications such as excessive bleeding during surgery.

Bristol Myers said the co-packaged product would be distributed in different dosage combinations, ranging from 20 mg to 80 mg of Pravachol combined with either 81 mg or 325 mg of buffered aspirin. But Keenan said a fixed-dose combination was also still under development.

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