Neuroleptic Malignant Syndrome News and Research

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Alzheimer's drug Aricept (donepezil) linked to serious side effects

New warnings have been added to the prescribing information for the Alzheimer's drug Aricept (donepezil) advising of the risk of two rare but potentially serious conditions: muscle breakdown (rhabdomyolysis) and a neurological disorder called neuroleptic malignant syndrome (NMS).

21 Jan 2015

Winners of NMSIS scholarship award

Two winners have been selected for the Promising New Investigators Travel Scholarship Awards given annually by the Neuroleptic Malignant Syndrome Information Service (NMSIS).

10 Mar 2010

Seroquel XR supplemental NDA recommended for approval

The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for Seroquel XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD).

9 Apr 2009

FDA approves Symbyax for treatment-resistant depression

The U.S. Food and Drug Administration (FDA) has approved a new indication for Symbyax (olanzapine and fluoxetine HCl capsules), Eli Lilly and Company has announced.

23 Mar 2009

Lilly receives complete response letter for Olanzapine LAI for treatment of schizophrenia

Eli Lilly and Company has announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults.

7 Jan 2009

Paliperidone palmitate shows positive results for treatment of schizophrenia

Paliperidone palmitate, an investigational long-acting therapy (LAT) demonstrated statistically significant symptom control compared with placebo according to the results of a 13-week study.

14 Dec 2008

AstraZeneca submits sNDA for SEROQUEL XR for treatment of major depressive disorder

AstraZeneca has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once- daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients.

1 Mar 2008

AstraZeneca submits sNDAs for SEROQUEL XR for bipolar symptoms

AstraZeneca has announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.

3 Jan 2008

FDA approves INVEGA treatment for schizophrenia

The U.S. Food and Drug Administration (FDA) has approved INVEGA (paliperidone) Extended-Release Tablets, a new once-daily, atypical antipsychotic, for the long-term maintenance treatment of schizophrenia.

30 Apr 2007