NDA
20-358
Glaxo
Wellcome Inc.
Attention:
James E. Murray
Director,
Regulatory Affairs STAMPED:
Five
Moore Drive Oct
4 1996
Research
Triangle Park, North Carolina 27709
Dear
Mr. Murray:
Please
refer to your New Drug Application (NDA) dated and received February 28, 1994,
submitted pursuant to section 505(b) of the Federal Food, Drug and Cosmetic Act
for Wellbutrin* (bupropion Hydrochloride) 50, 100, and 150 mg Sustained Release
SR Tablets, NDA 20-358, for the treatment of depression.
We
also refer to an Agency approvable letter dated March 12, 1996, and we also
acknowledge receipt of your additional communications dated March 25, May 14,
August 15, August 19, and August 29, 1996, providing for responses to our
approvable letter.
Reference
is also made to a conference call dated September 12, 1996, between the Agency
and representatives from Glaxo Wellcome to discuss labeling issues, drug
product expiration dating, and dissolution specifications for Wellbutrin* SR.
We
have competed our review of this application, as amended, and have concluded
that adequate information has been presented to demonstration that the drug
product is safe and effective for use as recommended in the draft labeling faxed
to you on September 4, 1996, and agreed upon, with minor modifications, in our
conference call dated September 12, 1996.
According, the application is approved effective as of this date of this
letter.
Accompanying
this letter (ATTACHMENT) is the labeling, including the revisions agreed to,
that should be used for marketing this drug product. These revisions are terms of the NDA approval. Marketing the product before making the
agreed upon revisions in the product’s labeling may render the product misbranded
and an unapproved new drug.
We
have the following additional comments:
Clinical
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