Review and Evaluation of
Clinical Data
NDA #20,358
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Sponsor: |
Burroughs Wellcome Co. |
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Drug: |
Wellcome (Bupropion HCl) SR |
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Material Submitted: |
Revised Labeling |
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Correspondence Date: |
September 22, 1995 |
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Date Received: |
September 25, 1995 |
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Related NDAs |
18644 |
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I. Description
of Compound |
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A. Generic
Name: |
Bupropion HCl |
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B. Drug
Category: |
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C: Formulation: |
Sustained release tablets |
II.
Background
Wellbutrin SR is the trade name for bupropion HCl
sustained release formulation (BSR) made by Burroughs Wellcome Co.. Wellbutrin immediate release tablets are
currently marketed. The sponsor
received a non-approvable letter for BSR because three placebo controlled
studies failed to show that the drug was effective at the proposed dose of 300
mg/day (150 mg po BID). The sponsor was
informed that approval of the drug would be considered if they supplied for
approval based on bioequivalence of BSR to the immediate release formulation of
bupropion (BIR). This would require the
sponsor to submit new labeling that would change the recommended dose range to
the existing bioequivalent range (300-450 mg/day), supply safety data for the
BSR proposed dose range, and include the information on adverse events
associated with the BIR and BSP in the labeling.
III.
Data Reviewed – Proposed labeling for Wellbutrin SR
Description Section: The proposed labeling is uniquely for the sustained release formulation, Wellbutrin SR. The description section, therefore, deletes the description of Wellbutrin and describes Wellbutrin SR. Further references to “Wellbutrin” immediate release formulation is changed to the generic bupropion immediate release throughout the proposed labeling.
Clinical Pharmacology Section: New information is added to this section regarding basic science findings that shed light on the proposed mechanism of action of bupropion. A reference is made to an animal tox/path study that examines the seizure thresholds of
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