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NRx Pharmaceuticals收到FDA信函,内容涉及对其不含防腐剂氯胺酮产品拟议标签的微小警告变更的评论,该公司预计将于四月提交最终标签

2026-04-06 19:05

  • NRx has received a letter from the FDA Office of Generic Drugs indicating preliminary alignment on labeling for NRx's preservative-free ketamine product. Labeling remains subject to final supervisory review.
  • NRx previously received a preliminary determination of bioequivalence for this product.
  • The Company continues to anticipate a decision on approval under the Generic Drug User Fee Act (GDUFA) in Summer 2026.

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