Alkermes files sNDA for two-month dosing for Aristada in schizophrenia
Ireland-incorporated biotech firm Alkermes (Nasdaq: ALKS) has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for a two-month dosing interval of Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.
This potential new two-month offering would expand the range of Aristada dosing intervals to include a third option for patients with schizophrenia. Aristada was approved by the FDA in October 2015 as the first long-acting atypical antipsychotic with once-monthly and once-every-six-weeks dosing options.
Patent allowance
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