Originally Published PMPN
September 2003
NEWS
First Copackaged Drug ApprovedErik Swain
FDA has announced the approval of Pravigard PAC, two copackaged drugs to treat cardiovascular disease and reduce the chance of heart attack. The drug regimen from Bristol-Myers Squibb Co. (Princeton, NJ) includes Pravachol and buffered aspirin, both of which are used to help prevent cardiovascular events.
According to FDA, Pravachol lowers the amount of bad (or LDL) cholesterol and raises the amount of good (or HDL) cholesterol. High cholesterol levels can lead to plugs or clots in blood vessels. Buffered aspirin stops the normal blood clotting process and keeps clots from forming in blood vessels that can lead to myocardial infarctions or strokes.
Pairing the two drugs provides an added convenience for the patient and also aids compliance. The usual dose of Pravigard PAC is one aspirin tablet with one Pravachol tablet once a day. The carton contains 30 daily doses arranged on six cold-formed foil blister cards. Each card contains five side-by-side blisters-one with a buffered aspirin tablet and one with a Pravachol tablet. The drug regimen underwent a standard review, and FDA approved it in approximately 12 months.
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