Aquestive Therapeutics announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the company’s New Drug Application (NDA) for Anaphylm, an epinephrine sublingual film intended to treat anaphylaxis. The FDA’s response indicates that additional information is needed, specifically related to human factors data.
The company stated it is addressing the FDA’s feedback and aims to resubmit the application in the third quarter of this year after making the necessary adjustments.
**Why this matters**
Anaphylm represents a novel approach to epinephrine delivery for patients experiencing anaphylaxis, potentially offering a more convenient alternative to injectable forms. The FDA’s request for further data highlights the importance of ensuring the product’s safety and usability before approval. The outcome of this resubmission will be critical for Aquestive’s development plans and market entry.
Source: NewsData