Russell G. Katz, M.D.

July 3, 2003

Page 7

 

2.      In addition, we have the following comments with respect to the container labeling for the new drug product:

A.     Container labeling (150 and 300 mg tablets, packages of 7 and of 30 tablets)

1.      The phrase “extended-release tablets” should be included within the brackets of the established name so that it reads: (bupropion hydrochloride extended-release tablets)

2.      The phrase “extended-release tablets” should appear in the same font as ‘bupropion HCl” and should be at least ½ the size of the proprietary name.

3.      The [blacked out] is distracting and should be deleted, or moved to a less prominent location.  The strengths, “150 mg” and “300 mg”, on the lids of the cartons that contain 12 bottles of 7 tablets should be made more prominent by, for example, increasing the font size.

 

Item 2 contains the revised container and carton labeling.

 

B.     Carton Labeling (carton containing 12 bottles of 7 tablets)

1.      Please see comments A.1 through A.3. above.

 

Item 2 contains the revised container and carton labeling.

 

C.     Patient Sample Kit (1 bottle of 150 mg strength (7 tablets) and one bottle of 300 mg strength (7 tablets))

 

GSK has decided not to develop a patient kit at this time.

 

D.     Shipping Carton (Contains 4 Sample Kits)

1.      See comments C.1 through C.4., above.

 

Item 2 contains the revised container and carton labeling.

 

 

Promotional Materials

 

In your complete response to this letter, please also submit three copies of the introductory promotional materials that you propose to use for this product.  Please submit all material in draft or mock-up form rather than final printed format.  Please send one copy to this Division and two copies of both the promotional material and the package insert  directly to the Division of Drug Marketing, Advertising, and Communications.

 

 

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