NRx Pharmaceuticals Gets Fast-Track Designation for NRX-101 UTI Treatment
2024年1月16日 - 9:25PM
Dow Jones News
By Chris Wack
NRx Pharmaceuticals has received qualified infectious disease
product and fast-track designation from the U.S. Food and Drug
Administration for NRX-101 in the treatment of complicated urinary
tract infections and pyelonephritis.
Receipt of QIDP designation confers priority review, and five
additional years of data-exclusivity to NRX-101's intellectual
property position.
The FDA also granted NRX-101 fast-track designation for cUTI,
which additionally allows for rolling submission of the company's
New Drug Application.
NRx has composition of matter patent protection on NRX-101
through at least 2033 in all major global markets. NRx is seeking
partners with active involvement in urology, infectious disease
and/or women's health for commercialization of NRX-101.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 16, 2024 07:10 ET (12:10 GMT)
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