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XORTX Starts Gout Program New Drug Application Talks With FDA
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XORTX Starts Gout Program New Drug Application Talks With FDA
Feb 24, 2025 5:08 AM

07:55 AM EST, 02/24/2025 (MT Newswires) -- Xortx Therapeutics ( XRTX ) on Monday said it has submitted a Type C meeting request with the U.S. Food and Drug Administration for its XRx-026 program to treat gout. The meeting is expected to be held within 75 days of the FDA's receipt of the request.

The XRx-026 program is developing Xorlo to treat gout and the meeting will review the program and its readiness for submission of a New Drug Application.

"The key elements of the XRx-026 program have advanced sufficiently to warrant a robust program review with the FDA. Having completed the work the FDA requested be conducted on oxypurinol in an approval letter issued previously, this Type C meeting will determine the FDA's position prior to submitting a NDA for final marketing approval," Dr. Allen Davidoff, Xortx's Chief Executive said.

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