FDA approves first monotherapy standalone MDD treatment

Valerie A. Canady
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Abstract

The Food and Drug Administration (FDA) last week approved the supplemental New Drug Application (sNDA) for spravato (esketamine), CII nasal spray considered the first and only monotherapy for adults with major depressive disorder (MDD) for adults who have failed to respond to at least two oral antidepressants.

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美国食品和药物管理局(FDA)批准首个单药独立 MDD 治疗方案
美国食品和药物管理局(FDA)上周批准了spravato (esketamine)的补充新药申请(sNDA), spravato (esketamine)是CII鼻喷雾剂,被认为是治疗至少两种口服抗抑郁药无效的成人重度抑郁症(MDD)的第一种也是唯一一种单一疗法。
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