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FDA Approves Khedezla

FDA Approves Khedezla for Major Depressive Disorder

July 10, 2013 -- The United States Food and Drug Administration today approved Khedezla (desvenlafaxine) extended-release tablets for the treatment of major depressive disorder.

Khedezla contains the serotonin and norepinephrine reuptake inhibitor (SNRI) desvenlafaxine, which is also contained in Pristiq. Pristiq was approved by the FDA in 2008 and contains desvenlafaxine as the succinate salt.

Khedezla will be available in 50 mg and 100 mg strengths for once daily adminitration.

Most common in patients treated with Khedezla were nausea, dizziness, insomnia, hyperhidrosis (excessive sweating), constipation, drowsiness, decreased appetite, anxiety, and specific male sexual function disorders.

Khedezla is manufactured by AAIPharma for Osmotica Pharmaceutical Corp. based in Wilmington, NC.

Posted: July 2013

Khedezla (desvenlafaxine) FDA Approval History