
Fluvoxamine Extended-Release Capsules
Form: Extended-Release Capsules
Strength: Luvox CR
Reference Brands: Luvox(US); Fevarin(EU)
Category: Antipsychotropic Drugs
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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