---
title: "NRXP: FDA review nearly complete; manufacturing scaled for launch to address U.S. ketamine shortage"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/295423503.md"
description: "FDA review of the preservative-free ketamine ANDA is nearly complete, with only a minor manufacturing attestation pending and no major deficiencies identified. Manufacturing is being scaled up to five million units, and commercial preparations are underway to address U.S. drug shortages and capture significant market share.Based on DisclaimerThis is an AI-generated summary and may contain inaccuracies. Please verify any important information with the original source."
datetime: "2026-08-10T14:52:06.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/295423503.md)
  - [en](https://longbridge.com/en/news/295423503.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/295423503.md)
generator: "portal-rs"
---

# NRXP: FDA review nearly complete; manufacturing scaled for launch to address U.S. ketamine shortage

FDA review of the preservative-free ketamine ANDA is nearly complete, with only a minor manufacturing attestation pending and no major deficiencies identified. Manufacturing is being scaled up to five million units, and commercial preparations are underway to address U.S. drug shortages and capture significant market share.

Based on 

**Disclaimer**

This is an AI-generated summary and may contain inaccuracies. Please verify any important information with the original source.

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---
> **Disclaimer: This article is for reference only and does not constitute any investment advice.**