NRx’s Preservative-Free Ketamine ANDA Clears FDA Bioequivalence, Approval Due Summer 2026
FDA Office of Generic Drugs finds no bioequivalence deficiencies in NRx’s preservative-free ketamine ANDA, clearing a crucial hurdle for Summer 2026 approval as the first benzethonium chloride-free formulation. US-made product targets three-year room-temperature stability and sterility while leveraging a National Priority Voucher for domestic supply resilience.
1. FDA Bioequivalence Determination
FDA Office of Generic Drugs has identified no bioequivalence deficiencies in NRx’s preservative-free ketamine Abbreviated New Drug Application, marking a key preliminary milestone pending final supervisory review.
2. Preservative-Free Formulation Advantages
The product is the first ketamine infusion free of benzethonium chloride, aiming to demonstrate three years of room-temperature stability and sterility, and is backed by US and international patents.
3. Supply Chain Resilience and Voucher
Manufactured domestically, the ketamine formulation supports FDA’s strategic focus on critical drug supply chains and benefits from a Commissioner’s National Priority Voucher for establishing a US drug substance source.
4. Next Steps and Timeline
NRx anticipates a final FDA GDUFA decision in Summer 2026 and continues pursuing a separate New Drug Application under Fast Track to expand ketamine’s indication for severe depression treatment.