Posted by Michael Wonder on 23 Nov 2017
Alkermes’ new drug application for investigational product designed for initiation onto Aristada accepted for filing by U.S. FDA
16 November 2017 - FDA action expected by 30 June 2018.
Alkermes today announced that the new drug application for Aripiprazole lauroxil nanocrystal dispersion (ALNCD), a novel, investigational product designed for initiation onto Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia, has been accepted for filing by the U.S. FDA. The FDA has issued a target action date for the ALNCD application of 30 June 2018 under the Prescription Drug User Fee Act.
“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,” said Elliot Ehrich, M.D., Executive Vice President, Research and Development of Alkermes. “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.”
If approved, administration of ALNCD in conjunction with a single oral dose of 30 mg aripiprazole will replace the need for three weeks of concomitant oral aripiprazole with the first dose of Aristada. The ALNCD investigational product is designed for initiation onto any dose or duration of Aristada (441 mg, 662 mg or 882 mg monthly, 882 mg once every six weeks, and 1064 mg once every two months).
