Russell
G. Katz, M.D.
July
3, 2003
Page 4
CMC: Methods Validation
We have not completed validation of the regulatory methods for this application. We will expect our continued cooperation to resolve any problems that may be identified.
GSK
commits to continue its cooperation with the Agency to resolve any problems
associated with confirming the validation of the analytical methods contained
in NDA 21-515 for Wellbutrin XL Tablets.
CMC: Categorical Exclusion
We have completed our review of the Environmental Assessment information provided by your firm, and we agree with your request for a Categorical Exclusion from the requirement to perform a full Environmental Assessment for this application.
Thank
you for completing this review.
Apparatus: USP
Apparatus 1 (Basket) at 75 RPM
Medium: 900
mL of 0.1N hydrochloric acid at 37±0.5°C
Specifications: 2
hours: [blacked out]
4
hours [blacked out]
8
hours [blacked out]
16
hours [blacked out]
Sample Size: 12
tablets for each time point in the dissolution profile
Item 6 contains the dissolution method and proposed specifications for both Wellbutrin XL Tablets, 150mg and 300mg.
2. Bupropion hydroxylated by CYP2B6. Recently, in vitro studies have identified more substrates and inhibitors of CYP2B6, and the results of recent in vitro studies suggest that several SSRIs and antiretroviral drugs may inhibit the hydroxylation of bupropion by CYP2B6. It would be useful to characterize the requirement for dosing modifications, if necessary, when such drugs are given concomitantly with
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