NRx Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a filing fee waiver for its upcoming New Drug Application (NDA) for NRX-100 (preservative-free ketamine). This waiver exempts the company from a $4.3 million NDA submission fee under the Prescription Drug User Fee Act (PDUFA).
The FDA granted the waiver at its discretion, recognizing both the product's public health value and NRx's qualification as a Small Business Entity. This financial relief enables the company to complete its New Drug Application for NRX-100, which is being developed to treat patients with suicidal depression.
This development is a significant positive for NRx, as it reduces immediate financial burden and underscores the FDA's acknowledgment of NRX-100's importance in addressing a critical unmet medical need. The company anticipates this waiver will facilitate the timely completion of its NDA submission.
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