Replies to post #113146 on Biotech Values

[DewDiligence]

…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?

Please see #msg-59152083.

[OakesCS]

re the part about "When is an amendment redesignated?"

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.

looks to me that receiving an initial response of 'minor deficiencies' does not mean that the deficiencies can not evolve to major deficiency status.