What is the generic name?

BUPROPION HYDROCHLORIDE

What is the Trade Name for BUPROPION HYDROCHLORIDE?

Forfivo XL

What are the Indications for BUPROPION HYDROCHLORIDE?

• 1 INDICATIONS AND USAGE FORFIVO XL (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies ( 14 )] . The physician who elects to use FORFIVO XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. FORFIVO XL is an aminoketone antidepressant indicated for the treatment of major depressive disorder (MDD) ( 1 ). The efficacy was established in two 4-week trials, one 6-week trial with bupropion immediate-release formulation, and one maintenance trial with bupropion sustained-release formulation, all in adults ( 14 ). Periodically re-evaluate long-term usefulness for the individual patient ( 1 ).

References: https://open.fda.gov/