Janssen Announces U.S. FDA Approval of SPRAVATO ® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior
TITUSVILLE, N.J. – (August 3, 2020) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation orbehavior.1 SPRAVATO® is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours,1 providing a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect. 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®. SPRAVATO® carries a Boxed Warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors. See below for Important Safety Information. SPRAVATO® will be made available at REMS certified treatment centers. Janssen is working to responsibly educate and certify treatment centers in accordance with the REMS so healthcare providers can offer SPRAVATO® to appropriate patients.Click to Tweet: #BREAKINGNEWS: FDA approves a new indication for @JanssenUS medicine for depressive symptom improv...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
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