FDA approves cariprazine resubmission
The U.S. Food and Drug Administration (FDA) acknowledged the receipt of Actavis' new drug application resubmission for the antipsychotic cariprazine, Hungarian drugmaker Gedeon Richter and Dublin-based peer Actavis reported today.
“We believe the resubmission of the cariprazine NDA includes the necessary data to address FDA’s comments and continue the review of this innovative treatment option,” said David Nicholson, Actavis Senior Vice President, Global Brands R&D.
Cariprazine (RGH-188) is an antipsychotic drug under development by Gedeon Richter and the license on development was obtained, together with exclusive commercial rights in the United States, by Forest Laboratories in 2004. Last year, Forest Laboratories was acquired by Actavis.
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