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May 1, 2008

Why Did the FDA Object to Merck's Cordaptive Brand Name?

mercklogo.pngThe news that Merck's new Cordaptive drug was unexpectedly torpedoed by the FDA has raised eyebrows across the industry, not least because the FDA
rejected the name as well, leading Derek at In the Pipeline to wonder what Merck will do with "all their promotional freebies."

This seems to be the least of Merck's problems this week.

There are a number of scientific and political reasons that probably doomed Cordaptive, but the FDA has yet to give a specific reason.

I have some thoughts on why Cordaptive may have been given a not-approvable letter.

Cordaptive is a cholesterol reducing drug from Merck that combines niacin, which can cause the unfavorable side affects of flushing and hot flashes, with laropiprant, which mitigates niacin’s side affects.

But Merck also markets Zocor, which also is designed to reduce cholesterol.

Additionally, there is Vytorin, a combination of Zocor and Zetia, which has proven to be no more effective than Zocor alone at reducing heart attaches or strokes.

Perhaps the FDA felt the "cor" prefix in Cordaptive suggested that the new product was an adaptation of Zocor. Or perhaps there were other reasons.

Merck changed the Cordaptive name to Tredaptive, which was approved by EMEA or the European Medicines Agency.

It will be interesting to see what the FDA decides regarding the Tredaptive name and the drug itself.

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Posted by William Lozito at May 1, 2008 8:22 AM
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