BioCentury
ARTICLE | Company News

FDA accepts NDA for Lutathera

August 28, 2017 10:10 PM UTC

Advanced Accelerator Applications S.A. (NASDAQ:AAAP) said FDA accepted for review a resubmitted NDA for Lutathera (177-Lu-Dotatate) to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. The PDUFA date is Jan 26, 2018.

FDA issued a complete response letter for the candidate last December. Advanced Accelerator had said the letter did not ask for additional trials, but requested subgroup and safety analyses, and asked the company to resolve manufacturing concerns (see BioCentury Extra, Dec. 21, 2016). ...

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