The
proposed in vitro dissolution method is acceptable. The office of clinical pharmacology and Biopharmaceutics
recommends that the specification be changed to the following:
2
hours: [blacked out]
4
hours: [blacked out]
8
hours: [blacked out]
16
hours: [blacked out]
In
addition, it should be noted that the Sponsor has not consistently used
[blacked out] tablets for each time point in the dissolution profiles. In the
future, the Sponsor should adhere to the practice of using [blacked out] for
dissolution profiles.
The
Office of Clinical Pharmacology and Biopharmaceutics (OCPB) recommends some
revisions in the proposed label text.
Please refer to Section 5.
The
Division of Scientific Investigations (DSI) has been requested to inspect the
clinical site and bioanalytical facilities (Biovail Contract Research, Toronto)
of the pivotal BE study.
AK1BIOVALIL2543 (“A Two-Way, Crossover, Steady State, Multiple-Dose,
Open-Label Fasting Comparative Bioavailability Study of Bupropion HCl 300 mg
Extended-Release Tablets (1 x 300 mg Q.D.) vs WELLBUTRIN 100 mg Tablets (TID)
in Normal Healthy Non-Smoking Male and Female Subjects). The DSI inspection report is pending.
The
OCPB finds that the submitted data in NDA 21-515 is acceptable pending the
outcome of the DSI inspection report.
STAMPED: Appears This Way on Original
7
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