FDA extends review period for Richterʼs cariprazine to September 2015


The American Food and Drug Administration (FDA) said it needs a three-month extension to complete its review of data supporting the resubmission of the New Drug Application (NDA) for cariprazine, Hungarian drugmaker Gedeon Richter and Dublin-headquartered peer Allergan, previously Actavis, said this morning in a press release.

Cariprazine is being reviewed for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Richter earlier expected the product to receive FDA approval for distribution in the United States by the end of Q2. At the beginning of January, the FDA acknowledged receipt of cariprazine.

In mid-January, Richter Gedeon announced successful tests of the antipsychotic drug cariprazine. "No treatment emergent adverse event was reported in more than 10% of the patients. The most frequent adverse events (incidence ≥5%) across both treatments groups were insomnia, headache, akathisia, worsening of schizophrenia symptoms, anxiety and somnolence," the announcement said.

Richter submitted the New Drug Application for cariprazine in late 2012 in the United States. The FDA requested further information in November 2013, and the application was resubmitted in January 2015.

Cariprazine was discovered by Richter and developed jointly with peer Actavis (currently named Allergan). Distribution rights for the United States and Canada were obtained by Actavis.


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