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NRXP: FDA가 케타민 ANDA에서 단일 주요 결함(major deficiency)을 확인
FDA completed first-round review of NRXP’s preservative-free ketamine ANDA with no drug-related deficiencies. One major deficiency was cited for the luer-lock vial tip; FDA requested manufacturer certifications that the vial is identical to three already-approved ANDAs. FDA committed to immediate re-review and shortest possible cycle.
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nrxp20260806_8k.htm false 0001719406 0001719406 2026-08-07 2026-08-07 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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): August 7, 2026 NRX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-38302 82-2844431 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification Number) 1201 Orange Street, Suite 600 Wilmington , Delaware 19801 (Address of principal executive offices) (Zip Code) ( 484 ) 254-6134 (Registrant ’ s telephone number, including area code) Not applicable (Former name or former address, if changed sinc