News Releases
New ADHD Rx Gets FDA Nod
Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company with a late‐stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention-deficit/hyperactivity disorder (ADHD), today announced that the U.S. Food and Drug Administration (FDA) approved Adzenys XR-ODT™ for the treatment of ADHD in patients six years and older. With this approval, Adzenys XR-ODT is the first and only extended-release orally disintegrating tablet (ODT) for the treatment of ADHD.
Chewable ADHD Rx Approved
Pfizer today announced that the U.S. Food and Drug Administration (FDA) has approved QuilliChew ER chewable tablets.
Schizophrenia, Bipolar Disorder Rx Approved
DUBLIN and BUDAPEST, Hungary, Sept. 17, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN) and Gedeon Richter Plc. announced today that the U.S. Food and Drug Administration (FDA) has approved VRAYLAR™ (cariprazine) capsules, an atypical antipsychotic, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults.
FDA Approves New Schizophrenia Rx
There’s a new treatment option for schizophrenia – INVEGA TRINZATM (three-month paliperidone palmitate), the first and only schizophrenia medication to be administered just four times a year, providing the longest dosing interval available.
FDA Approves New Use for Invega Sustenna
Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA® SUSTENNA® (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy.
Step Forward for Rx to Treat Rare Mental Condition
The FDA has granted "Orphan Drug" status to a medication in the treatment of a rare disorder linked to autism.
FDA Approves Second Brain Imaging Rx for Alzheimer’s Disease, Dementia Evaluation
The US Food and Drug Administration today approved Vizamyl ( flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia.
Forest Laboratories and Pierre Fabre Laboratories Announce FDA Approval of FETZIMA
Forest Laboratories, Inc. and Pierre Fabre Laboratories announced today that FETZIMA™ (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI), discovered by Pierre Fabre Laboratories and co-developed by Forest Laboratories, Inc. was approved by the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults.
FDA Approves Abilify Maintena for Schizophrenia
The US Food and Drug Administration (FDA) has approved ABILIFY MAINTENA™ (aripiprazole) for extended release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia.
FDA Approves Adasuve for Agitation with Schizophrenia, Bipolar I
Alexza Pharmaceuticals, Inc. announced today that the US Food and Drug Administration (FDA) approved Adasuve ( loxapine ) Inhalation Powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.