Russell
G. Katz, M.D.
July
3, 2003
Page
3
The
sampling plan has been revised to verify that samples of the drug product are
taken at the beginning, middle, and end of the manufacturing process. The updated sampling plan is provided in
Item 4, Section P6.1.
3.
The relative response factors associated with each impurity / degradant
should be incorporated into the formulas used for calculating the impurity /
degradant levels. The impurity / degradant
levels should be recalculated using the relative response factors. In addition, the impurity / degradant limits
should be recalculated for the drug product.
The
updated analytical method incorporating the relative response factors is
included in Item 4, Section P6.4. The
primary stability data for the drug-related [blacked out] have
been recalculated and are presented in Item 4, Section P9.3. Updated drug product specifications that
reflect the revised specifications are provided in Item 4, Section P6.2.
4.
Provide a complete and detailed description of the secondary packaging
systems for the [blacked out] bottles [blacked out] Your response should include specifications
and in-process controls.
[blacked out]
5.
Please provide updated drug product stability information
Included
in this amendment is the recalculated stability data (Item 4, Section P9), the
updated drug product specifications (Item 4, Section P6.2), and the updated
statistical analysis of the stability data (Item 4, Section P9.4). SAS Transport files are also provided.
We have also incorporated the revised storage statement (previously agreed upon between yourselves and our chemistry review team) into the overall revised labeling (package insert) appended to this letter. Please address this change in all labeling elements, including container and carton labeling as well as the package insert, when submitting your complete response.
Item 2 contains the revised product labeling (package insert) and labeling for the containers and cartons. Additionally, the revised storage statement is provided in Item 4, Section P9.4.4.
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