FDA Alert News

FDA Approves Zyprexa for Schizophrenia, Bipolar Disorder in Teens

December 5th, 2009
FDA Approves Zyprexa for Schizophrenia, Bipolar Disorder in TeensThe U.S. Food and Drug Administration (FDA) handed Eli Lilly & Co. approval to market its best-selling medication Zyprexa to teens with schizophrenia or bipolar ...

FDA Warns Pregnant Women Taking Depakote, Depakene

December 5th, 2009
FDA Warns Pregnant Women Taking Depakote, DepakeneThe U.S. Food and Drug Administration (FDA) last week notified health care professionals and patients about the increased risk of neural tube defects ...

Seroquel Gains FDA Approvals for Add-on Depression Treatment, Pediatric Schizophrenia

December 5th, 2009
Seroquel Gains FDA Approvals for Add-on Depression Treatment, Pediatric Schizophrenia The U.S. Food and Drug Administration (FDA) announced this past week that two types of Seroquel-brand (quetiapine fumarate) atypical antipsychotic medications have been approved ...

New Treatment for Schizophrenia and Bipolar Disorder

August 14th, 2009
New Treatment for Schizophrenia and Bipolar DisorderThe U.S. Food and Drug Administration (FDA) has approved Saphris tablets (asenapine) to treat adults with schizophrenia or bipolar disorder. "Mental illnesses like schizophrenia and bipolar disorder can be ...

Invega Antipsychotic Approved for Schizophrenia, Schizoaffective Disorder

August 6th, 2009
Invega Antipsychotic Approved for Schizophrenia, Schizoaffective DisorderLast week, the U.S. Food and Drug Administration (FDA) handed down two new approvals for Invega (paliperidone), an atypical antipsychotic medication, for the treatment of schizoaffective disorder, and ...

Once-Daily Trazodone Rejected by FDA

July 20th, 2009
Once-Daily Trazodone Rejected by FDAA once-daily form of trazodone, a second-generation antidepressant that has been available for the treatment of depression for decades, has been rejected by the U.S. Food ...

Chantix, Zyban Users Warned of Risk of Suicide, Depression

July 1st, 2009
Chantix, Zyban Users Warned of Risk of Suicide, DepressionThe U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking ...

FDA Urges Caution on Heart Findings from ADHD Drug Study

June 15th, 2009
FDA Urges Caution on Heart Findings from ADHD Drug StudyThe U.S. Food and Drug Administration (FDA) urged caution on interpreting the findings from a new study published on Monday that showed an increase in ...

FDA Panel Recommends Approval of Seroquel, Geodon and Zyprexa for Children, Teens

June 10th, 2009
FDA Panel Recommends Approval of Seroquel, Geodon and Zyprexa for Children, TeensThree atypical antipsychotics -- Seroqiel, Geodon, and Zyprexa -- were voted to be “acceptably safe” and effective for the treatment of schizophrenia ...

FDA Panel Recommends Approval of Seroquel for Teens

June 10th, 2009
FDA Panel Recommends Approval for Seroquel for TeensSeroquel was voted to be "acceptably safe" and effective for the treatment of schizophrenia in teenagers, said a U.S. Food and Drug Administration (FDA) panel of outside ...