AzedraTreatment for Pheochromocytoma; Paraganglioma
Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for Azedra (iobenguane I 131)
NEW YORK, March 22, 2018 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (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.
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.”
Progenics develops innovative medicines and other technologies to target and treat cancer. Progenics' pipeline includes: 1) therapeutic agents designed to precisely target cancer (Azedra ®, 1095, and PSMA TTC), 2) PSMA-targeted imaging agents for prostate cancer (1404 and PyL™), and 3) imaging analysis technology. Progenics' first commercial product, RELISTOR® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with Valeant Pharmaceuticals International, Inc.
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Source: Progenics Pharmaceuticals Inc.
Posted: March 2018
- Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for Azedra (iobenguane I 131) in Pheochromocytoma and Paraganglioma - December 29, 2017
- Progenics Pharmaceuticals Completes Submission of NDA for Azedra (iobenguane I 131) in Pheochromocytoma and Paraganglioma - November 2, 2017