Treats major depressive disorder (MDD). NDA 22497, held by Twi Pharms. Bupropion Hydrochloride.
As of Nov 14, 2026, NDA 22497 (Forfivo Xl), held by Twi Pharms, was first approved by FDA on Nov 10, 2011, with 6 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 10, 2011 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Forfivo Xl450MG · tablet, extended release;oral | Bupropion Hydrochloride | RxReference drug |
| Nov 5, 2025 | Supplement 18Labeling · Standard review | Approved | |
| May 7, 2024 | Supplement 15Labeling · Standard review | Approved | |
| Dec 10, 2019 | Supplement 8Labeling · Standard review | Approved | |
| May 4, 2017 | Supplement 4Labeling · Standard review | Approved | |
| Aug 30, 2016 | Supplement 3Labeling · Standard review | Approved | |
| Jul 17, 2014 | Supplement 2Labeling | Approved | |
| Nov 10, 2011 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
