Aquestive menerima pemberitahuan kekurangan FDA untuk Anaphylm NDA

FDA memberitahu Aquestive tentang kekurangan dalam Anaphylm (epinephrine) Sublingual Film NDA yang menghalangi diskusi pelabelan dan komitmen pasca-pemasaran. Pemberitahuan ini bukan merupakan keputusan akhir dan tinjauan masih berlangsung. Perusahaan sedang berupaya menyelesaikan masalah sebelum tanggal target PDUFA 31 Januari 2026, tetapi perkembangan ini berpotensi menunda persetujuan.

Fakta utama

Diajukan: 9 Jan 2026, 12.18
Peristiwa: Surat tanggapan lengkap
Arah: Negatif
Perusahaan: AQSTAquestive
Aset: epinephrine
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 31 Jan 2026 · Surat tanggapan lengkap

Kutipan sumber

aqst-20260109 0001398733 false 0001398733 2026-01-09 2026-01-09 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): January 9, 2026 Aquestive Therapeutics, Inc. (Exact name of Registrant as specified in its charter) Delaware 001-38599 82-3827296 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) 30 Technology Drive Warren , NJ 07059 ( 908 ) 941-1900 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices) Not Applicable (Former name or former address, if changed since last report) ______________________

SEC 8-K