Fluvoxamine Tablets

Form: Tablets

Strength: 25 mg, 50 mg, 100 mg

Reference Brands: Luvox(US); Fevarin(EU)

Category: Antipsychotropic Drugs

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.