Desvenlafaxine Extended-Release Tablets
Form: Extended-Release Tablets
Strength: 25 mg, 50 mg, 100 mg
Reference Brands: Pristiq®(US & EU), Khedezla®(US)
Category: Antipsychotropic Drugs
In the United States, desvenlafaxine extended-release tablets are FDA-approved for the treatment of major depressive disorder (MDD) in adults. As an SNRI, it requires a Boxed Warning regarding the risk of suicidal thoughts and behaviors in young individuals. Regulatory compliance includes GMP manufacturing, bioequivalence studies for generics, and ongoing post-marketing surveillance. Labeling must reflect FDA-approved indications, dosing, and adverse effects. In the European Union, desvenlafaxine is not widely marketed, but regulatory pathways exist for national or decentralized approval. Applications must include clinical efficacy, pharmacovigilance plans, and Risk Management Plans (RMPs). For compliant global 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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