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.
