ISSUE1433
The FDA has approved the marketing of another extended-release brand-name formulation of the serotonin and norepinephrine reuptake inhibitor (SNRI) desvenlafaxine (Khedezla – Par/Osmotica) for treatment of depression. It is the third extended-release formulation of desvenlafaxine to become available in the US. Khedezla was approved using a 505(b)(2) application, a new drug application (NDA) that relies upon the FDA's findings of safety and/or effectiveness for a previously approved drug.
Khedezla does not appear to offer any advantage over the other extended-release formulations of desvenlafaxine. There is no evidence that any formulation of desvenlafaxine is more effective for treatment of depression than other SNRIs or any SSRI, which are available in less expensive generic formulations.1
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