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FDA accepts NDA for Aristada dispersion product
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The FDA recently accepted for filing a New Drug Application for aripiprazole lauroxil NanoCrystal Dispersion, an investigational product designed for initiation to Aristada extended-release injectable suspension, for treatment of schizophrenia, according to a release from Alkermes.
The New Drug Application was submitted in October 2017.
“The acceptance of this filing marks a significant milestone as we seek approval for aripiprazole lauroxil NanoCrystal Dispersion as a novel product designed for initiation onto Aristada for the treatment of schizophrenia,” Elliot Ehrich, MD, executive vice president of research and development of Alkermes, said in a press release. “We look forward to working with the agency in the coming months with the goal of bringing this potential new initiation product for Aristada to healthcare providers and their patients as quickly as possible.”
The FDA issued a target action date of June 30, 2018 under the Prescription Drug User Fee Act.
If approved, NanoCrystal Dispersion used in conjunction with a single 30-mg oral dose of aripiprazole may replace the need for 3 weeks of concomitant oral aripiprazole with the first dose of Aristada.
NanoCrystal Dispersion is designed for initiation of any dose or duration of Aristada.