一次情報の記録
重要その他
NRx、ケタミンANDAの初回FDA審査を完了；重大な医薬品欠陥なし
防腐剤フリーケタミンのANDAは、医薬品関連の重大な欠陥なしで初回FDA審査を完了した。残る唯一の項目（バイアルに関する製造業者証明）は提出済み。同社は現在、上市在庫として500万回分の製造を開始しており、2026年の承認および商業化を目標としている。
主要事実
出典の抜粋
EX-99.1 2 ex_1005774.htm EXHIBIT 99.1 ex_1005774.htm Exhibit 99.1 NRx Pharmaceuticals (Nasdaq:NRXP) Reports Second Quarter 2026 Financial Results and Provides Corporate Update; Conference Call to be Held on Monday, August 17 th at 4:30pm ET Key recent and second quarter highlights include: ● Completed first-cycle FDA review of the Company’s ANDA for preservative-free ketamine with no drug-related major deficiencies. The sole remaining item, a manufacturer's attestation on the vial, has been submitted to FDA. ● Initiation of commercial scale manufacturing of preservative-free ketamine building to launch stock of 5 million doses to be ready for commercialization in 2026. ● Selected by the Defense Advanced Research Projects Agency (DARPA) as prime contractor for SPARC-TMS, an FDA-appro