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Replies to post #107207 on Biotech Values
DewDiligence
10/25/10 7:37 PM
#107208 RE: tekcor_atnm #107207
03/16/11 9:46 AM
#116510 RE: tekcor_atnm #107207
Though Amphastar’s Amended Complaint alleges no end of intrigue in FDA’s refusal to approve the company’s application to make a generic enoxaparin product, a single fact is fatal to all of Amphastar’s claims: Amphastar has not satisfied the statutory requirements for approval of a generic drug.