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DewDiligence

12/26/09 10:38 PM

#331 RE: OakesCS #330

The FDA regulates Lovenox and other heparin-based products as small-molecule drugs rather than biologics. Hence, the Lovenox ANDA’s pending at the FDA do not depend on—and are not affected by—enactment of the provisions in the Senate healthcare bill. Regards, Dew