FDA approves Allergan and Gedeon Richter's antipsychotic Vraylar

18 September 2015

The US Food and Drug Administration yesterday approved Vraylar (cariprazine) capsules, an atypical antipsychotic from Hungary’s largest drugmaker Gedeon Richter (RICHT: HB) and Ireland-headquartered Allergan (NYSE: AGN), for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults.

Shares of Gedeon Richter advanced 5.13% to 14.50 euros in early trading this morning, while Allergan’s stock dipped 0.9% to $301.05 after-hours in New York last night.

"We are pleased with the FDA approval of Vraylar, which represents an important new treatment option for adults living with bipolar I disorder and schizophrenia to help address the unmet medical needs of people with these complex conditions," said David Nicholson, executive vice president and president of global R&D brands of Allergan, adding: "This approval reinforces our deep commitment to the mental health community, as we continue to build our robust CNS portfolio."

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