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10nisman

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10nisman

Re: zipjet post# 107825

Tuesday, 11/02/2010 12:04:41 PM

Tuesday, November 02, 2010 12:04:41 PM

Post# of 257259

We recently met with representatives of the FDA to discuss the status of our ANDA during the meeting we confirmed that our version of generic lovenox meets teh FDA's criteria to demonstrate chemical sameness and accordingly that data related to immunogenicity are currently under review at the office of biological products.

The FDA did not confirm Teva's ANDA met the FDA's chemical sameness criteria -- Teva (we) confirmed. Sounds to me like a creatively crafted introduction.

10nis
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