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Sunday, July 25, 2010

FDA Approves Generic Blood-Thinner, Opening Door For More Biotech Copycats

FDA Approves Generic Blood-Thinner, Opening Door For More Biotech Copycats

by Scott Hensley
NPR - July 23, 2010

Enoxaparin is a mouthful. But if you're at risk for developing blood clots, you might practice saying it.

The soothing female voice at Davis's Drug Guide says e-nox-a-PA-rin (click on link to listen). So why might you care?

Well, the Food and Drug Administration just gave a thumbs-up to a generic version of enoxaparin, an anticoagulant, that will be sold by a unit of the Swiss drug giant Novartis.

That's a big deal because for years the drug -- nearly a $3 billion-a-year seller in the U.S. -- has been available under the brand-name Lovenox from Sanofi-Aventis. The FDA also says pharmacists can substitute the generic drug for the brand. And it should be cheaper, too.

On all those counts, the generic approval is important. But even more significant, the FDA's approval of generic Lovenox, which is a complicated mixture of long chains of sugars, shows the agency can move ahead on generic versions of biotech-style drugs.

The drugmaker now known as Sanofi-Aventis fought against the approval all the way. But the agency didn't buy the company's arguments, which are refuted here.

As Forbes Robert Langreth explains, the FDA requirements for generic Lovenox are "a test case" for how the agency could handle "copycat versions of complex biological drugs." [Copyright 2010 National Public Radio]

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