date must remain at 18 months until better data can be submitted. They agreed to this condition.
6.0
DISSOLUTION SPECIFICATIONS
In
our approvable letter, we recommended a dissolution specification for all
tablet strengths. However, in the 5-14-96
response, the sponsor submitted data that they considered supportive of
different specifications for each of the 3 strengths. We disagree on this matter and conveyed to the sponsor in our
9-12-96 teleconference our view that the single set of specifications proposed
in our approvable letter would have to be applied. They agreed to this condition.
7.0
CONCLUSION AND RECOMMENDATIONS
All
matters have been addressed for the NDA and I recommend that we issue the attached
approval letter along with the mutually agreed upon product labeling.
cc:
Orig
NDA 20-358
HFD-120/DivFile
HFD-120/TLaughren/PLeber/PAndreason/GDubitsky/PDavid
HFD-101/Rtemple
DOC:
MEMBRPSR.AP1
3
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