Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA on January 30, 2026 for a New Drug Application (NDA) for Anaphylm (dibutepelin). Anaphylm is a sublingual film indicated for the treatment of type I allergic reactions including anaphylaxis in patients weighing 30 kg or more[1][2][3][4][5]. A CRL means that an approval request is not approved in its current form and identifies deficiencies that need to be addressed[1][3]. The shortcomings relate exclusively to packaging, administration and human factors such as opening the package, tearing the foil, chewing errors or incorrect placement[1][2][3][4]. The FDA did not report problems with pharmacokinetics, repeat-dose safety, manufacturing (CMC), or comparable data[1][2][4]. The company plans to modify the opening mechanism, add pictorial instructions, conduct a new human factors validation with about 75 participants, and a supporting PK study[2][4]. Aquestive expects to resubmit the NDA as early as the third quarter of 2026 and will request an expedited review with a timeframe of around six months[1][2][3][4].