EA Review #1, NDA 20-358

Page 3

b.      Need for Action:

          Bupropion (WELLBUTRIN) is a chemically unique antidepressant which has been shown to be           well tolerated and effective in treating depression.  It has been marketed as an immediate-release           tablet since 1989.

          The added benefit of sustained-release tablets over the presently marketed immediate-release           tablets should be stated.

          DEFICIENT

c.       Production Locations:

       i.      Proprietary Intermediate(s):

                  It should be confirmed that none of the input materials are proprietary intermediates that are                   manufactured at another location.

                  DEFICIENT

          ii.     Drug Substance:

                  The drug substance will be synthesized at Burroughs Wellcome Co., Greenville, NC, and at                   the Wellcome Foundation LTD., Temple Hill, Dartford, Kent, UK.

                  The exact addresses for the facilities should be provided.

                  DEFICIENT

          iii.    Finished Dosage Form:

                  The drug product will be formulated at Burroughs Wellcome Co., Greenville, NC.

                  The exact address of this facility should be provided.

                  DEFICIENT