NDA 21-515

WELLBUTRIN XL

 

Clinical Pharmacology and Biopharmaceutics Review

 

NDA:	21-515
Brand Name:	Wellbutrin XL
Generic Name:	Bupropion HCl
Type of Dosage Form:	Extended Release Tablet
Strengths:	150 mg, 300 mg
Indications:	Major Depressive Disorder
Type of Submission:	NDA Response to Approvable Letter
Sponsors:	GlaxoSmithKline
Submission Date:	July 3, 2003
OCPB Division:	DPE-I
OND Division:	Division of Neuropharmacological Drug Products HFD-120
OCPB Team Leader:	Ramana Uppoor, PhD

 

 

1        Executive Summary

This review evaluates the Sponsor’s response to the recommendations made by the Office of Clinical Pharmacology and Biopharmaceutics (OCPB) in the approvable action letter for NDA 21-515.

 

In the review of the original NDA (See OCPB review of 5/12/03), based entirely on bioequivalence studies, the Office of Clinical Pharmacology and Biopharmaceutics recommended the following:

 

• A change in the in vitro dissolution specifications
• A literature review and adverse event review to evaluate the potential for drug interactions with CYP2B6 substrates/inhibitors, since in vitro studies have suggested that some SSRIs and some protease inhibitors inhibit CYP2B6-mediated hydroxylation of bupropion.
• Specific revisions of the proposed label’s text, including revisions regarding CYP2B6-mediated drug interactions.

 

 

The Sponsor has provided responses as follows:

• The Sponsor has provided justification for broadening the specification at 4 hours, and proposes the following dissolution specifications for WELLBUTRIN XL 150 and 300 mg tablets:

 

2 Hours:  

4 hours:  [blacked out]

8 hours:  

16 hours 

 

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