Aquestive Resubmits NDA for Anaphylm ' to FDA

Aquestive Therapeutics announced the resubmission of its New Drug Application (NDA) for Anaphylm (dibutepinephrine) sublingual film to the U.S. FDA for the treatment of Type I allergic reactions, addressing a previous Complete Response Letter. This regulatory milestone is a key step toward potentially bringing a needle-free, fast-acting treatment for anaphylaxis to market.