FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Janssen’s Fast-Tracked Nasal Spray Antidepressant Gets FDA Nod

March 13, 2019
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The FDA approved Johnson & Johnson’s Spravato (esketamine) nasal spray indicated for treatment-resistant depression in conjunction with an oral antidepressant.

The agency approved the drug through its fast-track and breakthrough therapy pathways, based on trial results that established the drug’s safety and efficacy and an endorsement from advisory committees.

The agency required a Risk Evaluation and Mitigation Strategy that restricts distribution to certified doctors’ offices and clinics.

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