What is the generic name?

ESKETAMINE HYDROCHLORIDE

What is the Trade Name for ESKETAMINE HYDROCHLORIDE?

Spravato

What are the Indications for ESKETAMINE HYDROCHLORIDE?

• 1 INDICATIONS AND USAGE SPRAVATO ¬Æ 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 SPRAVATO ¬Æ is a non-competitive N -methyl D -aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of: Treatment-resistant depression (TRD) in adults. ( 1 ) Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. ( 1 ) Limitations of Use: The effectiveness of SPRAVATO in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO. ( 1 ) SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO as an anesthetic agent have not been established. ( 1 ) Limitations of Use: The effectiveness of SPRAVATO in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated [see Clinical Studies (14.2) ] . Use of SPRAVATO does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO. SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO as an anesthetic agent have not been established.

References: https://open.fda.gov/