Evicenter
P&T meetings

Anaphylm (dibutepinephrine)

Type I allergic reactions including anaphylaxis

Also known as AQST-109
Regulatory submission
NDA resubmitted September 2026
Launch
Not announced
Last updated
121 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatment

Ongoing post-approval monitoring

1 evidence topic · 1 source

Post-marketing commitments discussed during FDA review

“As the PDUFA data approached, the FDA notified the Company that it had identified deficiencies in the NDA that precluded discussion of labeling and post-marketing commitments and that the FDA review remained ongoing.” (opens the source at this quote in a new tab)

Risk evaluation and mitigation strategy, registries, and post-marketing surveillance

No evidence found.