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What will be the FDA's decision on Unicycive's NDA for Oxylanthanum Carbonate by November 3, 2024?
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Resolution / Starting Odds
Accepted • 33%
Rejected • 33%
Request for additional information • 34%
FDA official announcements and Unicycive Therapeutics press releases
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Unicycive ($UNCY) Submits NDA for Oxylanthanum Carbonate, Awaits FDA Acceptance
Sep 4, 2024, 09:04 AM
Unicycive Therapeutics ($UNCY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The submission follows the 505(b)(2) regulatory pathway. Unicycive has partnered with Shilpa Medicare to provide end-to-end contract development and manufacturing organization (CDMO) services. The next steps include FDA acceptance and setting a PDUFA date.
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