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zipjet

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zipjet

Re: go seek post# 107822

Tuesday, 11/02/2010 11:51:35 AM

Tuesday, November 02, 2010 11:51:35 AM

Post# of 253125

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.



by Schlomo ......

Marth confirmed this though less articulately.

ij

There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)

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