US FDA approves Alkermes's Aristada two-month dosing option.
M2 PHARMA-June 8, 2017-US FDA approves Alkermes's Aristada two-month dosing option
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The US Food and Drug Administration (FDA) has approved Ireland-based Alkermes's two-month dosing option of Aristada intended to treat schizophrenia, it was reported yesterday.
The product is an extended-release injectable atypical antipsychotic which, after entering into the body, is converted to aripiprazole. The drug has now been approved by US FDA in four doses and three dosing duration options. The company stated that it can be initiated by healthcare providers at any dose or interval.
Overall, the company's approvals from the US FDA include once-monthly, once-every-six-weeks and once-every-two-months dosing options. Following the approval of the two-month dosing option, schizophrenia patients in the United States now have the opportunity to have their symptoms treated with only six injections per year. Alkerma is set to launch the two-month dose of Aristada during this month.
The FDA originally approved Aristada in October 2015.
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