New Drug Application (NDA): Back to the Basics | LexisNexis Reed Tech
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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
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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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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