Request that the FDA take the following actions: (i) refrain from approving Aquestive Therapeutics, Inc.s (AQST) New Drug Application (NDA), submitted under section 505(b)(2) of the Act, for the prodrug, AQST-109 Epinephrine Sublingual Film (Anaphylm) without additional testing for review regarding the product’s safety and efficacy; and (ii) require a Boxed Warning for the product, if the Unite | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-4612

Request that the FDA take the following actions: (i) refrain from approving Aquestive Therapeutics, Inc.s (AQST) New Drug Application (NDA), submitted under section 505(b)(2) of the Act, for the prodrug, AQST-109 Epinephrine Sublingual Film (Anaphylm) without additional testing for review regarding the product’s safety and efficacy; and (ii) require a Boxed Warning for the product, if the Unite

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 2, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Arnall Golden Gregory, LLP	Feb 27, 2026	--

Comment Statistics

Total Comments

Keywords

CDER

Citizen Petition

Arnall Golden Gregory, LLP

refrain from approving

Aquestive Therapeutics, Inc.’s

(AQST) New Drug Application (NDA)

prodrug, AQST-109 Epinephrine

Sublingual Film (Anaphylm)

Data from Regulations.gov