Case Study: ANDA Approval for a Generic Antidepressant
Case Study: ANDA Approval for a Generic Antidepressant Inside the ANDA Approval Journey for a Generic Antidepressant Introduction: Why CNS Drugs Pose Unique Challenges Antidepressants, especially selective serotonin reuptake inhibitors (SSRIs), represent a vital class of CNS drugs with widespread use. The regulatory approval of a generic version of an antidepressant drug requires robust bioequivalence…
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