FDA Alerts
Modified Monitoring for Rx Clozapine
The U.S. Food and Drug Administration (FDA) is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia.
New Schizophrenia Rx Approved
On July 10, the U.S. Food and Drug Administration approved Rexulti (brexpiprazole) tablets to treat adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).
First Generic Abilify Approved
The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole).
FDA Expands Uses of Vyvanse to Treat Binge-Eating Disorder
The U.S. Food and Drug Administration today expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.
FDA Warns of Rare but Serious Skin Reactions from Ziprasidone
FDA is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body.
FDA Approves New Type of Sleep Medication
The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).
Rare Risk of Long-Lasting Erections from ADHD Medications
FDA is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism.
Cymbalta Goes Generic
The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.
FDA Approves New Drug to Treat Major Depressive Disorder
The US Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
FDA Permits Marketing Test to Help Assess Children and Teens for ADHD
The US Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old.