Advanced Accelerator Applications Receives Complete Response Letter from FDA for Lutathera®, an Investigational Treatment for Neuroendocrine Tumors
No Additional Clinical Studies Requested
SAINT-GENIS-POUILLY, France, Dec. 21, 2016 (GLOBE
NEWSWIRE) -- Advanced Accelerator Applications S.A.(NASDAQ:AAAP)
("AAA" or the "Company"), an international specialist in
Molecular Nuclear Medicine (MNM), today announced that following the issuance
of a previously disclosed Discipline Review Letter (DRL) in November, the U.S.
Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)
regarding the New Drug Application (NDA) for Lutathera® for the
treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
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