FDA Reclassifies NRx Pharmaceuticals' Ketamine ANDA Amendment To Minor, Setting New Goal Date For November 10, 2026
Abbreviated New Drug Application (ANDA) Amendment related to the drug vial for preservative-free ketamine has been reclassified from a Major Amendment to a Minor Amendment.FDA has revised the Generic Drugs User Fee Act
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Why It Matters
NRx's ketamine drug application got easier to approve. Now the FDA expects a decision by late 2026.
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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.
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