WELLBUTRIN (bupropion hydrochloride)

ENVIRONMENTAL ASSESSMENT INFORMATION

 

 

1.                   DATE

 

27 July 1995

 

2.                   APPLICANT/PETITIONER

 

Burroughs Wellcome Co.

 

3.                   ADDRESS:

 

3030 Cornwallis Rd.

Research Triangle Park, NC 27709

 

4.                   DESCRIPTION OF PROPOSED ACTION

 

4.a                Describe the requested approval

 

Burroughs Wellcome Co. has filed a New Drug Application (NDA 20-358) for approval to manufacture, package, and market WELLBUTRIN † (bupropion hydrochloride) Sustained-Release Tablets containing 50, 100, and 150 mg of bupropion hydrochloride for the treatment of depression.

 

4.b                Describe the need for the action

 

Bupropion hydrochloride (WELLBUTRIN) , an aminoketone compound, is a chemically unique antidepressant not related to the tricyclics/tetracyclics, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors or other known antidepressant agents.  In placebo-controlled studies, WELLBUTRIN has been shown to be well tolerated and effective in treating depression.

 

Mode (Mechanism) of Action: The antidepressant activity of bupropion hydrochloride is presumed to be mediated primarily through pathways subserved by norepinephrine as evidenced by its ability to reduce firing rates of norepinephrine containing neurons in the locus coeruleus at doses which are active in animal antidepressant models.  The mechanism of this effect is unknown.  Bupropion hydrochloride is a weak blocker of norepinephrine uptake, a very weak blocker of serotonin reuptake, and blocks the reuptake of dopamine to some extent.  Bupropion hydrochloride does not inhibit monoamine oxidase.

 

 

 

†This is a Trade Mark of Wellcome group companies.

  Registered in U.S. Patent and Trademark Office.

 

 

 

 

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