Levomilnacipran Extended-Release Capsules
Form: Extended-Release Capsules
Strength: 20 mg, 40 mg, 80 mg, 120 mg
Reference Brands: Fetzima®(US)
Category: Antipsychotropic Drugs
Levomilnacipran extended-release (ER) capsules are FDA-approved in the United States for the treatment of major depressive disorder (MDD) in adults. As a serotonin-norepinephrine reuptake inhibitor (SNRI), the ER formulation provides consistent plasma levels and once-daily dosing. U.S. regulations mandate boxed warnings for increased suicidal thoughts in young adults, GMP-compliant manufacturing, bioequivalence studies for generics, and post-marketing pharmacovigilance. In the European Union, levomilnacipran is not widely marketed, but companies may pursue national or decentralized procedures for approval. EU requirements include a comprehensive Risk Management Plan (RMP), clinical safety and efficacy data, and robust pharmacovigilance measures. For dossier-ready sourcing, visit Pharmatradz.com.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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