Allergan caps a bad day with news the FDA has kicked back a supplemental application for cariprazine
Allergan $AGN is not having a good day today.
After posting some mixed, weak extended year-two data on its NASH drug, the company ended the day with a short note that the FDA had issued a refuse-to-file letter on its supplemental application for cariprazine as a new therapy for negative symptoms associated with schizophrenia.
The drug was already approved for schizophrenia and the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder. According to Allergan, the FDA told them that their application “was not sufficiently complete to permit a substantive review.”
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