Paroxetine Tablet (Extended-Release)
Form: Tablet (Extended-Release)
Strength: 12.5 mg, 25 mg, 37.5 mg
Reference Brands: US: Paxil®, Pexeva®, Brisdelle®; EU: Seroxat®, ParoMerck®, Paxetin®
Category: Antipsychotropic Drugs
Paroxetine extended-release tablets are FDA-approved in the USA for treating major depressive disorder (MDD), panic disorder, social anxiety disorder, and generalized anxiety disorder. As a selective serotonin reuptake inhibitor (SSRI), they require a Boxed Warning for increased suicidality risk in young adults, along with compliance to GMP, labeling regulations, and post-marketing surveillance under FDA’s pharmacovigilance programs. In the EU, while immediate-release formulations are more common, extended-release versions must meet EMA or national agency approval standards, including Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs). Explore dossier-ready supplies at 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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