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Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for AZEDRA
Mar. 23, 2018 09:03AM PST
Pharmaceutical InvestingProgenics Pharmaceuticals (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, announced today that the Company has received notification from the U.S. Food and Drug Administration (FDA) that the Agency will extend its review of the New Drug Application (NDA) for AZEDRA® (iobenguane I 131) by three months to July 30, …
Progenics Pharmaceuticals (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, announced today that the Company has received notification from the U.S. Food and Drug Administration (FDA) that the Agency will extend its review of the New Drug Application (NDA) for AZEDRA® (iobenguane I 131) by three months to July 30, 2018.
As quoted in the press release:
The extension is the result of the submission of additional Chemistry, Manufacturing, and Controls (CMC) information by Progenics, which required additional time for FDA review. The standard three-month extension is not related to the efficacy or safety data of AZEDRA.
“We remain confident in our NDA submission and are committed to bringing AZEDRA forward as an option for patients with malignant pheo and para,” said Mark Baker, Chief Executive Officer of Progenics. “We look forward to continuing our dialogue with the Agency as we prepare for a potential approval of AZEDRA.”
