Fetzima

Product manufactured by Allergan Usa, Inc.

Application Nr Approved Date Route Status External Links
NDA204168 2013-07-25 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage 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. Fetzima Is A Serotonin And Norepinephrine Reuptake Inhibitor (snri) Indicated For The Treatment Of Major Depressive Disorder (mdd) (1). 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 (1).

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Ethylcelluloses ETHYLCELLULOSES Unresolved
2. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
3. Povidones POVIDONES Unresolved
4. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Hypromelloses HYPROMELLOSES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Levomilnacipran Hydrochloride LEVOMILNACIPRAN HYDROCHLORIDE ZINC506

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