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Indications and Limitations of Use:

Esketamine CIII Nasal Spray is indicated, in conjunction with an oral antidepressant, for the treatment of:

• Treatment-resistant depression (TRD) in adults.
• Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.

Limitations of Use:

• The effectiveness of the Esketamine Intranasal Spray in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of Esketamine does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of Esketamine Intranasal Spray.
• Esketamine Intranasal Spray is not approved as an anesthetic agent. The safety and effectiveness of Esketamine as an anesthetic agent have not been established.