Response to our proposed labeling
-We
provided draft labeling and asked the sponsor to either accept our proposal or
propose alternative language.
-The
sponsor [blacked out] We negotiated final labeling with the
sponsor, and reached agreement on 8-20-03.
DSI
Although
the pivotal equivalence study was done in Toronto, it was not possible to
inspect this site due to travel restrictions.
Thus, the records were shipped to a Chantilly, VA facility, and they
were inspected there between June 9th and 13th by DSI staff. While there were minor deficiencies, in
particular, incorrect reporting of data for 1 patient and inadequate SOPS,
overall, the data were deemed to be acceptable for review. The data were reanalyzed by OCPB staff, with
corrected values for the patient in question, and the result was unchanged.
Conclusion
-All
issues is our approvable letter have been addressed, and this application can
now be approved with the mutually agreed upon final labeling.
cc:
Orig
NDA 21-515
HFD-120/DivFile
HFD-120/TLaughren/RKatz/PAndreason/RLevin/DBates/RTaylor
DOC:
NDA21515.02
3
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