Milnacipran Film-Coated Tablets

Form: Film-coated Tablets

Strength: Film-coated Tablets

Reference Brands: Savella(US); Ixel®, Toledomin(EU)

Category: Antipsychotropic Drugs

In the United States, milnacipran film-coated tablets are FDA-approved primarily for the management of fibromyalgia, not for depression, although it's classified as a serotonin-norepinephrine reuptake inhibitor (SNRI). Regulatory requirements include boxed warnings for increased suicidal risk in young adults, GMP compliance, and post-marketing surveillance. Manufacturers must provide evidence of bioavailability, long-term safety, and labeling accuracy. In the European Union, milnacipran is approved under various national procedures for the treatment of major depressive disorder (MDD), with less emphasis on fibromyalgia. EU regulations mandate a Risk Management Plan (RMP), pharmacovigilance systems, and Periodic Safety Update Reports (PSURs). For dossier-ready supply and partnerships, visit Pharmatradz.com.