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Re: DewDiligence post# 79501

Saturday, 06/13/2009 1:29:01 AM

Saturday, June 13, 2009 1:29:01 AM

Post# of 257268
MNTA: Is there any way to determine what the chances that if/when the FDA approves a generic Lovenox, M-Enoxaparin would be the only one approved for a significant amount of time?

I had read an article back a few years that Amphastar's product had significant differences in mass spectrometry compared to Lovenox. I think that was back in 2005.

What testing does the company do to determine equivalency? Mass spec, chromatography, and or NMR?

I'm hoping we get a response from the FDA soon. Not sure how long Teva will take to catch up, if they even can.

From listening to the Goldman presentation, I think Craig Wheeler said they believe they still have a significant lead over their competition with their technology, know-how and trade secrets.

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