FDA Assigns March 2027 Review Date for Anaphylm Epinephrine Film

The FDA has accepted the resubmitted New Drug Application for Anaphylm, a sublingual epinephrine film designed for needle-free treatment of type I allergic reactions. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027, for its review. This decision provides a clear timeline for the potential approval and commercial launch of this orally administered epinephrine option.