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Item
#3
FDA
Clears Bristol-Myers to Co-Package Statin With Aspirin
Called “Pravigard PAC’
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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