Phenelzine Tablets

Form: Tablets

Strength: 15 mg

Reference Brands: Nardil®(US)

Category: Antipsychotropic Drugs

Phenelzine tablets are FDA-approved in the United States for the treatment of major depressive disorder (MDD), particularly in patients unresponsive to other therapies. As a non-selective, irreversible MAOI, phenelzine requires strict regulatory oversight due to risks such as hypertensive crisis and serotonin syndrome. U.S. regulations mandate Boxed Warnings, patient guides, and GMP-compliant manufacturing. Bioequivalence data is needed for generic versions. In the European Union, phenelzine is either rarely used or available through special access programs, due to safety concerns and dietary restrictions. EU dossiers, if applicable, must include Risk Management Plans (RMPs) and robust pharmacovigilance. For global sourcing, visit Pharmatradz.com.