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Biotech Stocks Facing FDA Decision In May 2019

Allergan
Allergan

The FDA decision on ALLERGAN plc’s (AGN) supplemental New Drug Application for Vraylar, seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults is expected in May.

Vraylar received its initial approval in the U.S. in September 2015 for the treatment of schizophrenia and bipolar disorder in adults. In November 2017, the drug received additional approval in the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder in adults.

The drug registered net revenue of $487.1 million in 2018 compared to $287.8 million in 2017.

AGN closed Thursday’s trading at $141.49, up 1.31%.