Fluvoxamine Extended-Release Capsules Luvox CR Suppliers & Bulk Manufacturers

Available Forms: Extended-Release Capsules

Available Strengths: Luvox CR

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

Category: Antipsychotropic Drugs

Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that increases serotonin levels in the brain, helping regulate mood and behavior. The extended-release formulation offers once-daily dosing. It is primarily used to treat obsessive-compulsive disorder (OCD) and social anxiety disorder (SAD) in adults, improving both intrusive thoughts and anxiety symptoms.

Product Description: In the United States, fluvoxamine extended-release (ER) capsules are FDA-approved for the treatment of obsessive-compulsive disorder (OCD) and social anxiety disorder (SAD). As a selective serotonin reuptake inhibitor (SSRI), it carries a Boxed Warning for increased risk of suicidal thoughts in adolescents and young adults. Regulatory compliance includes GMP standards, bioequivalence data for generics, and strict labeling and safety reporting. Ongoing pharmacovigilance is required through FDA’s FAERS system. In the European Union, fluvoxamine is typically available in immediate-release tablet form, with the ER capsule less commonly approved. EU regulatory approval follows centralized or national procedures, with mandatory Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and comprehensive clinical data. For regulatory-ready sourcing, visit Pharmatradz.com.