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reedtech.com
New Drug Application (NDA): Back to the Basics | LexisNexis Reed Tech
Reed Tech helps you understand the new drug application process and how the FDA regulates these requests.
Jul 23, 2021
New Drug Application New Drug Approval Process
0:14
Unicycive Therapeutics (Nasdaq: UNCY) announced resubmission of its 505(b)(2) New Drug Application (NDA) to the FDA for oxylanthanum carbonate (OLC), a phosphate binder for treating hyperphosphatemia in patients with chronic kidney disease on dialysis. A new PDUFA target date is expected in 1H 2026, within 30 days of the resubmission. Unicycive Therapeutics is a B2i Digital Featured Company. View their comprehensive profile at b2idigital.com/unicycive. The resubmission reflects progress by the o
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