REUTERS: The U.S. Food and Drug Administration on Tuesday said it approved Johnson & Johnson's nasal spray antidepressant that is chemically similar to often-abused ketamine, marking the first advance in treating depression in more than 30 years.
Citing the risk of serious adverse outcomes and the potential for abuse and misuse, the FDA said the drug will be available through a restricted distribution system. The decision comes after an FDA advisory panel recommended approval of the drug, Spravato, which is designed to treat depression in patients who have not benefited from two or more antidepressants."There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Tiffany Farchione of the FDA's Center for Drug Evaluation and Research.
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