Wellbutrin XL NDA 21-515

Composition of WELLBUTRIN LX Tablets, 150 mg and 300 mg, as provided by Sponsor.

Component	150 mg Quantity (mg)	300 mg Quantity (mg)	Function	Reference to Standard
Bupropion Hydrochloride	150.0	300.0	Active Pharmaceutical Ingredient	Biovail
Polyvinyl Alcohol	*[whited out]*	*[whited out]*	*[whited out]*	USP
Glyceryl Behenate	*[blacked out]*	*[blacked out]*	*[blacked out]*	NF
Ethylcellulose *[blacked out]*	*[blacked out]*	*[blacked out]*	*[blacked out]*	NF
Povidone	*[blacked out]*	*[blacked out]*	*[blacked out]*	USP
Polyethylene Glycol *[blacked out]*	*[blacked out]*	*[blacked out]*	*[blacked out]*	NF
*[blacked out]*	*[blacked out]*	*[blacked out]*	*[blacked out]*	*[whited out]*
*[blacked out]*	*[blacked out]*	*[blacked out]*	*[blacked out]*	*[whited out]*
Methaccrylic Acid Copolymer Dispersion *[blacked out]*	*[blacked out]*	*[blacked out]*	*[blacked out]*	NF
Silicon Dioxide	*[blacked out]*	*[blacked out]*	*[blacked out]*	NF
Triethyl Citrate	*[blacked out]*	*[blacked out]*	*[blacked out]*	NF
Purified Water	*[blacked out]*	*[blacked out]*	*[blacked out]*	USP
*[blacked out]* Black Ink	*[blacked out]*	*[blacked out]*	*[blacked out]*	Biovail
Total unit dose	*[blacked out]*	*[blacked out]*	*[blacked out]*

Note: [blacked out]

4.1.2 What is the proposed mechanism of drug action and what is the proposed therapeutic indication?

Bupropion is an antidepressant of the aminoketone class. Its mechanism of action is unknown but is thought to be mediated by noradrenergic and/or dopaminergic mechanisms. According to the sponsor it inhibits neuronal reuptake of norepinephrine and dopamine and does not inhibit monoamine oxidase. The proposed indication is for the treatment of major depressive disorder.

4.1.3 What is the proposed dosage and route of administration?

The proposed adult target for WELLBUTRIN XL Tablets is 30 mg/day, given orally once daily in the morning. It is recommended that dosing begin at 150 mg/day as a single daily dose in the morning. If this does is adequately tolerated, an increase to 300 mg/day may be made as early as day 4 of dosing. An increase in dose to the maximum of 405 mg/day may be considered in patients with no clinical improvement after several weeks of treatment at 300 mg/day.

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