FDA approves Allergan and Gedeon Richter's antipsychotic Vraylar
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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