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Replies to post #113146 on Biotech Values
DewDiligence
01/25/11 12:49 PM
#113164 RE: ghmm #113146
…some time ago TEVA mentioned labeling discussions (I believe late '09…) …I thought we had the discussion on this board that this wouldn't be possible? If it would I am presuming that would mean its not fully substitutable?
OakesCS
01/25/11 1:52 PM
#113177 RE: ghmm #113146
In some cases, the results of a bioequivalence or labeling review will result in the redesignation of an amendment. For example, if an ANDA is in minor status for chemistry and it is subsequently determined that an in vivo bioequivalence study fails, a redesignation to major will occur.