Nov. 15 at 2:37 PM
$AQST From AI:
The FDA has not yet issued a decision on the citizen's petition filed by ARS Pharmaceuticals against Aquestive Therapeutics Anaphylm. The FDA is required to take final action on such petitions no later than 150 days after the date on which they are submitted.
On September 2025, ARS filed a Citizens Petition urging the FDA to delay the approval of Anaphylm, citing concerns over safety, dosing, and real-world efficacy, and requesting additional studies and potentially a boxed warning if approved.
The FDA will make a decision on the ARS petition within the regulatory timeframe, but the final outcome for Anaphylm will be part of the FDA's broader review process leading up to the PDUFA date. The agency may accept, deny, or dismiss the petition, but historically, such petitions filed by competitors to delay product approval have been denied. Aquestive has stated it worked closely with the FDA on the application and believes it meets rigorous review standards.
