Tardive dyskinesia is a neurological syndrome caused by the long-term use of neuroleptic drugs. Neuroleptic drugs are generally prescribed for psychiatric disorders, as well as for some gastrointestinal and neurological disorders. Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements. Features of the disorder may include grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. Rapid movements of the arms, legs, and trunk may also occur. Involuntary movements of the fingers may appear as though the patient is playing an invisible guitar or piano.
Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. today announced that the company is acquiring exclusive rights in the United States for Saphris (asenapine) sublingual tablets, a treatment for adult patients with schizophrenia or acute bipolar mania, from Merck Sharp & Dohme B.V., a wholly owned subsidiary of Merck & Co., Inc.
Auspex Pharmaceuticals announced today that the first patient has been enrolled in a multi-center Phase 3 pivotal trial of its lead investigational drug, SD-809 for the treatment of involuntary movements (chorea) associated with Huntington's Disease.
The Huntington Study Group (HSG), under the leadership of Samuel Frank, MD, Principal Investigator, (Boston University School of Medicine) and Claudia Testa, MD, PhD, co-Principal Investigator (Virginia Commonwealth University), is conducting a clinical trial with a formulation of the novel drug SD-809 in the treatment of HD the United States and Canada.
BD Rx Inc., a wholly-owned subsidiary of leading global medical technology company BD, announced today that the U.S. Food and Drug Administration has approved the second drug to be offered in the recently launched BD Simplist line of ready-to-administer prefilled generic injectables.
Neurocrine Biosciences, Inc. today announced that a Phase IIb clinical trial to evaluate elagolix for the treatment of uterine fibroids has been initiated.
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. 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.
Neurocrine Biosciences, Inc. today announced its financial results for the quarter and year ended December 31, 2012.
Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental New Drug Applications (sNDAs) for the use of LATUDA as 1) monotherapy and 2) adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with bipolar I disorder (bipolar depression).
Stopping treatment with risperidone to limit side effects risks the return of psychosis or agitation in patients with Alzheimer’s disease who have been taking the drug to suppress such symptoms, research shows.
Merz, Inc. today announced the acquisition of CUVPOSA (glycopyrrolate) oral solution for pediatric chronic severe drooling associated with neurologic conditions such as cerebral palsy.
Carrie Scott went in to the hospital for abnormal bleeding. Days later she returned home without her hand and forearm. The generic form of Phenergan was given improperly, apparently from an inadequate warning label. Scott has no legal recourse because a generic drug caused her injury, rather than its brand-name equivalent.
Neurocrine Biosciences, Inc. today announced efficacy and safety results from a Phase II trial of urocortin 2 in 53 patients with acute decompensated heart failure. The UNICORN study was conducted over approximately a two year period by the Cardioendocrine Research Group from the University of Otago in Christchurch, New Zealand and included patients admitted to Christchurch Hospital with acute decompensated heart failure.
Sunovion Pharmaceuticals Inc. today announced results from an open-label study that switched clinically stable, but symptomatic adult outpatients with schizophrenia from other antipsychotic agents to LATUDA.
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S today announced results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the maintenance treatment of adults with schizophrenia.
Dainippon Sumitomo Pharma Co., Ltd. announced today results from two Phase 3 clinical trials designed to evaluate the efficacy and safety of LATUDA as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone).
Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg.
AstraZeneca today announced that on March 7, 2012, the Food and Drug Administration denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for SEROQUEL (quetiapine fumarate) tablets and SEROQUEL XR (quetiapine fumarate) extended-release tablets.
Akorn, Inc., a niche generic pharmaceutical company, today announced that its wholly-owned subsidiary, Oak Pharmaceuticals, has acquired three off-patent, branded, hospital-based injectables from the US subsidiary of H. Lundbeck A/S.
AstraZeneca today announced it has entered into a settlement agreement in its U.S. SEROQUEL XR patent infringement litigation against Handa Pharmaceuticals, LLC regarding Handa's proposed generic version of AstraZeneca's SEROQUEL XR extended-release tablets.
Neurocrine Biosciences, Inc. announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the Company's proprietary Vesicular Monoamine Transporter 2 inhibitor, NBI-98854.