Alkermes Submits NDA for Injectable Abilify

Alkermes plc has submitted a new drug application (NDA) to the US Food and Drug Administration approval of aripiprazole lauroxil, the company's investigational, novel, once-monthly, long-acting injectable atypical antipsychotic for the treatment of schizophrenia.

Aripiprazole lauroxil is an injectable atypical antipsychotic with one-month and two-month formulations in development for the treatment of schizophrenia. Once in the body, aripiprazole lauroxil converts to aripiprazole, which is commercially available as Bristol-Myers Squibb’s Abilify. As a long-acting investigational medication based on Alkermes' proprietary LinkeRx technology, aripiprazole lauroxil is designed to have multiple dosing options and to be administered in a ready-to-use, pre-filled product format.

Source: Alkermes

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