NRXP: Tinukoy ng FDA ang isang pangunahing kakulangan sa ketamine ANDA

Nakumpleto ng FDA ang unang round na pagsusuri ng preservative-free ketamine ANDA ng NRXP nang walang kakulangan na may kaugnayan sa gamot. Isang pangunahing kakulangan ang binanggit para sa luer-lock vial tip; hiniling ng FDA ang mga sertipikasyon ng tagagawa na ang vial ay kapareho ng tatlong naaprubahang ANDA na. Nangako ang FDA ng agarang muling pagsusuri at pinakamaikling posibleng cycle.

Mahahalagang fact

Na-file: Ago 7, 2026, 11:00 AM
Kaganapan: Iba pa
Direksyon: Neutral
Kumpanya: NRXPNRX Pharmaceuticals
Asset: ketamine
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

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

SEC 8-K