Lacking on detail. This is the 2nd Complete Response Letter FROM THE FDA. Is it something new or is it an inadequate response to Mayne's response to the 1st Complete Response Letter? It is a positive that the manufacturing component of the ANDA has been considered approvable as that is the key part of an ANDA. What can be tricky with generics is the "bioequivalence" data, but if there was an issue that would have been raised in the 1st CRL.
Lacking on detail. This is the 2nd Complete Response Letter FROM...
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