If your mental health has seemed a little out of sorts for some time now, there’s a chance you’ve already spoken to a healthcare provider and been offered the common antidepressant sertraline. Whether ...

An FDA advisory panel has resoundingly rejected the supplemental new drug application for the atypical antipsychotic brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in combination with the ...

According to the letter, the application could not be approved due to lack of substantial efficacy from the submitted studies. The Food and Drug Administration (FDA) has issued a Complete Response ...

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce that Otsuka has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the ...

The advisory committee voted 10-1 against recommending brexpiprazole in combination with sertraline for PTSD based on the lack of efficacy. The Food and Drug Administration’s (FDA) Psychopharmacologic ...

PRINCETON, N.J. & TOKYO--(BUSINESS WIRE)--Otsuka America Pharmaceutical, Inc., (OAPI) and Otsuka Pharmaceutical, Co., Ltd. (Otsuka) announce that the U.S. Food and Drug Administration (FDA) plans to ...

People taking sertraline can experience a wide range of side effects, some that may warrant a 999 call. Sertraline is one of the most prescribed antidepressants in the UK, with around two million ...