Russell G. Katz, M.D.
August 28, 2003
Page 2
each tactic being developed. It is important to note GSK did not
distribute the “Coming Soon” letters to physicians and pharmacists as described
in the original proposal as we had not received feedback from the Division that
this strategy was appropriate.
GSK commits to having all components of the attached
Educational Communication Plan in place by December 15, 2003. On or before that time, the components of
this program will be provided to the Division.
As part of this overall commitment, all domestic medication error
reports or potential medication error reports associated with Wellbutrin XL
will be sent to the Agency as expedited reports (within 15 days).
If there are any questions regarding this submission
please contact me at 919-483-3763 or James Murray at 919-483-5119. Thank you.
Sincerely,
(Signature)
Mary E. Martinson
Director
Regulatory Affairs, Psychiatry
cc: Dr. Richardae Taylor (HFD-120)
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