Fluvoxamine Tablets Generics - Manufacturers & Suppliers
Luvox(US); Fevarin(EU)
| Product/Composition:- | Fluvoxamine Tablets |
|---|---|
| Strength:- | 25 mg, 50 mg, 100 mg |
| Form:- | Tablets |
| Reference Brands:- | Luvox(US); Fevarin(EU) |
| MOQ | As per the manufacturer batch size |
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Fluvoxamine tablets are selective serotonin reuptake inhibitors (SSRIs) that work by increasing serotonin levels in the brain to help improve mood and reduce anxiety. They are primarily used to treat obsessive-compulsive disorder (OCD) and depression, alleviating symptoms such as persistent thoughts, compulsive behaviors, and emotional imbalance in affected patients.
In the USA, fluvoxamine extended-release capsules are FDA-approved for the treatment of obsessive-compulsive disorder (OCD) and social anxiety disorder (SAD) in adults. As an SSRI, the product carries a Boxed Warning about increased risks of suicidal ideation in young adults. Regulatory requirements include GMP-compliant manufacturing, bioequivalence studies for generics, and continuous post-marketing safety monitoring through FDA’s FAERS database. Labeling must include specific safety and usage instructions aligned with approved indications. In the EU, fluvoxamine is generally available in immediate-release form, with extended-release capsules not widely marketed. Any future EU submissions must comply with EMA or national authority requirements, including Risk Management Plans (RMPs), clinical safety data, and pharmacovigilance systems. For dossier-ready supply and global distribution, visit Pharmatradz.com.