FETZIMA, a serotonin and norepinephrine reuptake inhibitor (SNRI) is indicated for the treatment of major depressive disorder (MDD). The efficacy of FETZIMA was established in three 8-week, randomized, double-blind, placebo-controlled studies in adult patients with a diagnosis of MDD [ see Clinical Studies (14)].
Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.
The active ingredient of FETZIMA is levomilnacipran, which is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of levomilnacipran is (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride; its empirical formula is C15H23ClN2O and its molecular weight is 282.8 g/mol. Levomilnacipran (Initial US approval: 2013) is the 1S,2R-enantiomer of milnacipran. The chemical structure is:
FETZIMA capsules are intended for oral administration only. Each FETZIMA capsule contains extended-release beads with 23.0, 45.9, 91.8, or 137.8 mg of levomilnacipran hydrochloride equivalent to 20, 40, 80, or 120 mg of levomilnacipran, respectively. Inactive ingredients include sugar spheres, ethylcellulose, talc, povidone, triethyl citrate, hypromellose, and titanium dioxide. Inactive ingredients also include shellac glaze, black iron oxide, yellow iron oxide (20 mg and 40 mg capsules only), and red iron oxide (80 mg and 120 mg capsules only).
Active Fetzima Ingredients
- Levomilnacipran Hydrochloride
Fetzima NDC Codes
|00456-2220-30||30||1 Plastic Bottle|
|00456-2220-63||10||1 Box Unit Dose|
|00456-2240-30||30||1 Plastic Bottle|
|00456-2240-90||90||1 Plastic Bottle|
|00456-2240-63||10||1 Box Unit Dose|
|00456-2280-30||30||1 Plastic Bottle|
|00456-2280-90||90||1 Plastic Bottle|
|00456-2280-63||10||1 Box Unit Dose|
|00456-2212-30||30||1 Plastic Bottle|
|00456-2212-90||90||1 Plastic Bottle|
|00456-2212-63||10||1 Box Unit Dose|
|00456-2202-28||1||1 Blister Pack|
Fetzima Structured Product Labels
|f371258d-91b3-4b6a-ac99-434a1964c3af||Forest Laboratories, Inc.|