Quetiapine Fumarate Extended-Release Tablets (Xr)

Form: Extended-Release tablets (XR)

Strength: 50 mg, 150 mg, 200 mg, 300 mg, 400 mg

Reference Brands: US: Seroquel®, Seroquel XR®; EU: Seroquel®, Seroquel Prolong®, Quetiapine Teva®

Category: Antipsychotropic Drugs

Quetiapine Fumarate XR tablets are FDA-approved in the USA for treating schizophrenia, bipolar disorder, and as an adjunct in major depressive disorder (MDD). Classified as an atypical antipsychotic, the drug mandates a Boxed Warning for increased suicidality in young adults and elderly dementia-related psychosis risks. Manufacturers must ensure GMP compliance, controlled labeling, and post-marketing safety reporting. In the EU, quetiapine XR is regulated via EMA or national authorizations, with stringent requirements for Risk Management Plans (RMPs), PSURs, and bioequivalence data. Explore dossier-ready, globally compliant quetiapine XR formulations at Pharmatradz.com.